Reduced pressure apparatus and methods

ABSTRACT

Some embodiments have a pump assembly mounted to or supported by a dressing for reduced pressure wound therapy. The dressing can have visual pressure, saturation, and/or temperature sensors to provide a visual indication of the level of pressure, saturation, and/or temperature within the dressing. Additionally, the pump assembly can have a pressure sensor in communication with the flow pathway through the pump, and at least one switch or button supported by the housing, the at least one switch or button being accessible to a user and being in communication with the controller. The pump assembly can have a controller supported within or by the housing, the controller being configured to control an operation of the pump. The pump can be configured to be sterilized following the assembly of the pump such that all of the components of the pump have been sterilized.

INCORPORATION BY REFERENCE

This application is a national stage application of International PatentApplication No. PCT/IB2013/000847, filed on Mar. 12, 2013, which claimspriority benefit of U.S. Provisional Patent Application No. 61/609,905filed Mar. 12, 2012, titled REDUCED PRESSURE APPARATUS AND METHODS. Thebenefit of priority is claimed under the appropriate legal basisincluding, without limitation, under 35 U.S.C. § 119(e). The disclosureof each of these prior applications is incorporated by reference in itsentirety and should be considered a part of this specification.

Additionally, further components and details of wound dressings, woundtreatment apparatuses, and negative pressure wound treatment methodsthat may be used with any of the embodiments disclosed in thisapplication are found in the following applications and/or patents,which are hereby incorporated by reference in their entireties as iffully set forth herein:

U.S. Patent Application Publication No. 2011/0282309 (Ser. No.13/092,042), (titled WOUND DRESSING AND METHOD OF USE), filed on Apr.21, 2011;

PCT Patent Application Publication No. WO 2011/087871 (InternationalPatent Application No. PCT/US2010/061938), (titled APPARATUS AND METHODSFOR NEGATIVE PRESSURE WOUND THERAPY), filed internationally on Dec. 22,2010;

U.S. Patent Publication No. 2009/0123513 (Ser. No. 11/922,894) (titledANTIMICROBIAL BIGUANIDE METAL COMPLEXES), filed on May 21, 2008;

PCT Patent Publication No. WO/2011/135284 (International PatentApplication No. PCT/GB11/000622) (titled WOUND DRESSING), filedinternationally on Apr. 21, 2011;

PCT Patent Publication No. WO/2011/144888 (International PatentApplication No. PCT/GB11/000621) (titled WOUND PROTECTION), filedinternationally on Apr. 21, 2011;

PCT Patent Publication No. WO/2011/135285 (International PatentApplication No. PCT/GB11/000625) (titled WOUND DRESSING), filedinternationally on Apr. 21, 2011;

PCT Patent Publication No. WO/2011/135286 (International PatentApplication No. PCT/GB11/000626) (titled MULTIPORT DRESSING), filedinternationally on Apr. 21, 2011;

PCT Patent Publication No. WO/2011/135287 (International PatentApplication No. PCT/GB11/000628) (titled SUCTION PORT), filedinternationally on Apr. 21, 2011;

PCT Patent Publication No. WO/2012/038724 (International PatentApplication No. PCT/GB11/051745) (titled PRESSURE CONTROL APPARATUS),filed internationally on Sep. 16, 2011;

U.S. patent application Ser. No. 13/287,897 (titled “REDUCED PRESSURETHERAPY APPARATUSES AND METHODS OF USING SAME), filed on Nov. 2, 2011;and

U.S. Patent Application Publication No. 2012/0136325 (Ser. No.13/287,959), (titled SYSTEMS AND METHODS FOR CONTROLLING OPERATION OF AREDUCED PRESSURE THERAPY SYSTEM), filed on Nov. 2, 2011.

BACKGROUND OF THE INVENTION

Field of the Invention

Embodiments disclosed herein relate to methods and apparatuses fordressing and treating a wound with topical negative pressure (TNP)therapy, namely dressing kits for TNP.

Description of the Related Art

Many different types of wound dressings are known for aiding in thehealing process of a human or animal. These different types of wounddressings include many different types of materials and layers, forexample, gauze, pads, foam pads or multi-layer wound dressings. Topicalnegative pressure (“TNP”) therapy, sometimes referred to as vacuumassisted closure, negative pressure wound therapy, or reduced pressurewound therapy, is widely recognized as a beneficial mechanism forimproving the healing rate of a wound. Such therapy is applicable to abroad range of wounds such as incisional wounds, open wounds andabdominal wounds or the like.

TNP therapy assists in the closure and healing of wounds by reducingtissue oedema; encouraging blood flow; stimulating the formation ofgranulation tissue; removing excess exudates and may reduce bacterialload and thus, infection to the wound. Furthermore, TNP therapy permitsless outside disturbance of the wound and promotes more rapid healing.

SUMMARY OF SOME EMBODIMENTS

Embodiments disclosed herein relate to methods and apparatuses fordressing and treating a wound with topical negative pressure (TNP)therapy. For example but without limitation, the embodiments disclosedherein relate to treating a wound with reduced pressure provided from apump kit. Although not required, any embodiments of the pump kit can beintegral, wherein the pump is mounted to or otherwise supported by oradjacent to the dressing. Additionally, although not required, anyembodiments of the pump kit can be sterile. As another non-limitingexample, some embodiments disclosed herein relate to apparatuses,features, and methods for controlling the operation of a TNP systemand/or apparatuses, features, and methods for detecting one or moreconditions or parameters of the dressing, such as pressure, temperature,or saturation level, and, although not required, controlling theoperation of the pump or other components of the dressing kitaccordingly. As another non-limiting example, any embodiments disclosedherein can be configured to provide a visual indication one or moreconditions or parameters of the dressing, such as pressure, temperature,or saturation level.

Any of the features, components, or details of any of the arrangementsor embodiments disclosed in this application, including those disclosedbelow, are interchangeably combinable with any other features,components, or details of any of the arrangements or embodimentsdisclosed herein to form new arrangements and embodiments. With that,the following arrangements are disclosed herein, inter alia.

1. A wound dressing kit for reduced pressure wound therapy, comprising:

-   -   a pump assembly;    -   a power source; and    -   a dressing member having one or more absorptive layers and a        fluid impermeable backing layer, and defining a first dressing        portion and a second dressing portion;    -   a score along at least a portion of the dressing member between        the first and the second dressing portions, the score being        configured to increase the tearability of the dressing member        between the first and second dressing portions;    -   wherein:        -   the first dressing portion is configured to support the one            or more absorptive layers; and        -   the second dressing portion is configured to support at            least one of the pump assembly and the power source.

2. The wound dressing kit of Arrangement 1, comprising a conduit influid communication with the pump assembly and the dressing member.

3. The wound dressing kit of any one of the previous arrangements,comprising a conduit in fluid communication with the pump assembly andthe dressing member, the conduit being selectively removable from thedressing member.

4. The wound dressing kit of any one of the previous arrangements,comprising a conduit positioned on a third dressing portion of thedressing member, the dressing member having a score along at least aportion of the dressing member between the first and the third dressingportions and/or the second and the third dressing portions, the scorebeing configured to increase the tearability of the dressing memberbetween the first and the third dressing portions and/or the second andthe third dressing portions.

5. The wound dressing kit of any one of the previous arrangements,comprising a conduit having perforated edges therealong and beingconfigured to extend about a perimeter of the first portion of thedressing member, the conduit being selectively detachable from the firstportion of the dressing member by tearing the conduit along at least oneperforated edge thereof.

6. The wound dressing kit of any one of the previous arrangements,comprising a conduit in fluid communication with the pump assembly andthe dressing member, the conduit being coiled about the pump assembly ina helical arrangement.

7. The wound dressing kit of any one of the previous arrangements,comprising a conduit in fluid communication with the pump assembly andthe dressing member having a connector on an end portion thereof, theconnector being configured to activate the pump assembly when engagedwith a second connector supported by the first dressing portion.

8. The wound dressing kit of any one of the previous arrangements,wherein the pump assembly comprises a voice coil actuated pump.

9. The wound dressing kit of any one of the previous arrangements,wherein the score comprises a plurality of perforations, channels,partial thickness cuts, and notches configured to increase thetearability of the dressing along the score.

10. The wound dressing kit of any one of the previous arrangements,wherein the power source is removable from the pump assembly by tearingthe dressing along a score in the second dressing portion between thepower source and the pump assembly.

11. The wound dressing kit of any one of the previous arrangements,wherein the pump is powered by a single 1200 mAh lithium battery.

12. The wound dressing kit of any one of the previous arrangements,wherein the pump is powered by one or more printed batteries.

13. The wound dressing kit of any one of the previous arrangements,wherein the pump is powered by one or more flexible batteries having athickness of from approximately 450 microns to approximately 770microns.

14. The wound dressing kit of any one of the previous arrangements,wherein the pump is powered by one or more flexible batteries having athickness of from approximately 450 microns to approximately 500microns.

15. The wound dressing kit of any one of the previous arrangements,wherein the pump is powered by 10 or more interconnected batteries.

16. The wound dressing kit of any one of the previous arrangements,wherein the pump is powered by one or more flexible batteries having athickness of less than approximately 500 microns.

17. The wound dressing kit of any one of the previous arrangements,wherein the pump assembly is powered by one or more flexible batteriespositioned about at least one of the first dressing portion and aconduit configured to communicate a source of negative pressure from thepump assembly to the one or more absorptive layers.

18. The wound dressing kit of any one of the previous arrangements,wherein the pump assembly is powered by one or more flexible batteriessupported by the first dressing portion beneath the backing layer.

19. The wound dressing kit of any one of the previous arrangements,wherein the pump assembly is powered by one or more flexible batteriessupported by the first dressing portion, the one or more flexiblebatteries being embedded within the one or more absorptive layers.

20. The wound dressing kit of any one of the previous arrangements,wherein the pump assembly is powered by one or more flexible batteriessupported by the first dressing portion outside of the backing layer.

21. The wound dressing kit of any one of the previous arrangements,wherein the pump assembly is powered by one or more air activatablebatteries.

22. The wound dressing kit of any one of the previous arrangements,wherein the dressing member has a wound contact layer and a transmissionlayer positioned between the wound contact layer and the backing layer.

23. The wound dressing kit of any one of the previous arrangements,wherein the pump is at least partially powered by one or morephotovoltaic cells.

24. The wound dressing kit of any one of the previous arrangements,wherein the pump is at least partially powered by one or morephotovoltaic cells positioned about at least one of the dressing backinglayer, a housing for the pump assembly, and a conduit configured tocommunicate a negative pressure provided by the pump assembly to the oneor more absorptive layers.

25. The wound dressing kit of any one of the previous arrangements,wherein the pump is at least partially powered by one or more batteriesattachable to the dressing member using snap connectors, adhesive,Velcro, a housing having a closeable opening, or a pouch supported bythe dressing member.

26. The wound dressing kit of any one of the previous arrangements,further comprising a flexible hinge positioned between the power sourceand the pump assembly to improve the flexibility and conformability ofthe portion of the dressing kit supporting the pump and the powersource.

27. The wound dressing kit of any one of the previous arrangements,comprising a V-shaped cut out in the dressing layer between the pumpassembly and the power source.

28. The wound dressing kit of any one of the previous arrangements,comprising a OLED display.

29. The wound dressing kit of any one of the previous arrangements,comprising a one or more indicator lights configured to indicate acondition of the dressing kit.

30. The wound dressing kit of any one of the previous arrangements,comprising a pull tab, button, conductive label, or switch configured toactivate the power source.

31. The wound dressing kit of any one of the previous arrangements,comprising a first packaging member configured prevent an electricalconnection between the power source and the pump assembly while thepower source is supported by the first packaging member.

32. The wound dressing kit of any one of the previous arrangements,comprising a pressure indicator supported by the first dressing portionconfigured to provide a visual indication of a level of pressure beneaththe backing layer.

33. The wound dressing kit of any one of the previous arrangements,comprising a saturation indicator supported by the first dressingportion configured to provide a visual indication of a level of liquidsaturation beneath the backing layer.

34. The wound dressing kit of any one of the previous arrangements,wherein the first portion of the dressing member has one or morefeatures or colored regions detectable only when the backing layer isdrawn against the one or more features or colored regions, the dressingkit being configured such that the backing layer is drawn against theone or more features or colored regions when a threshold level ofnegative pressure is achieved under the backing layer.

35. The wound dressing kit of any one of the previous arrangements,comprising an activation switch or button configured to move between afirst on position and a second off position, the switch or button beingconfigured to remain in the first position when a threshold level ofnegative pressure is maintained beneath the backing layer.

36. The wound dressing kit of Arrangement 36, wherein the switch orbutton is configured to move to the second position when the level ofnegative pressure under the backing layer is less than a threshold levelof negative pressure and the pump assembly exceeds a threshold flow rateor has been operating continuously for a threshold period of time.

37. The wound dressing kit of Arrangement 36, wherein the switch orbutton is configured to move to the second position when the level ofnegative pressure under the backing layer is less than 60 mmHg and thepump assembly has been operating continuously for 4 minutes.

38. The wound dressing kit of Arrangement 36, wherein the switch orbutton comprises a depressible dome and a tact switch.

39. A wound dressing kit for reduced pressure wound therapy, comprising:

-   -   a pump assembly;    -   a dressing member; and    -   a power source;    -   wherein the pump assembly and the power source are supported by        the dressing member.

40. The wound dressing kit of Arrangement 39, wherein:

-   -   the power source comprises a plurality of batteries positioned        about the dressing member;    -   the plurality of batteries are configured to provide a source of        power to at least the pump assembly; and    -   each of the plurality of batteries has a thickness of from        approximately 450 microns to approximately 700 microns.

41. The wound dressing kit of Arrangement 40, wherein the plurality ofbatteries each have a thickness of from approximately 450 microns toapproximately 500 microns.

42. The wound dressing kit of any one of Arrangements 39-41, wherein:

-   -   the dressing member comprises one or more absorptive layers and        a fluid impermeable backing layer, and defines a first dressing        portion and a second dressing portion;    -   the dressing member comprises a score along at least a portion        of the dressing member between the first and the second dressing        portions, the score being configured to increase the tearability        of the dressing member between the first and second dressing        portions;    -   wherein:        -   the first dressing portion is configured to support the one            or more absorptive layers; and

the second dressing portion is configured to support the pump assembly.

43. The wound dressing kit of any one of Arrangements 39-42, comprisinga conduit having perforated edges therealong and being configured toextend about a perimeter of the first portion of the dressing member,the conduit being selectively detachable from the first portion of thedressing member by tearing the conduit along at least one perforatededge thereof.

44. The wound dressing kit of any one of Arrangements 39-42, comprisinga conduit in fluid communication with the pump assembly and the dressingmember, the conduit being coiled about the pump assembly in a helicalarrangement.

45. The wound dressing kit of any one of Arrangements 39-44, wherein thepump assembly comprises a voice coil actuated pump.

46. The wound dressing kit of any one of Arrangements 39-45, comprisinga pull tab, button, conductive label, or switch configured to activatethe power source.

47. The wound dressing kit of any one of Arrangements 39-46, comprisinga pressure indicator supported by the dressing member configured toprovide a visual indication of a level of pressure beneath the backinglayer.

48. The wound dressing kit of any one of Arrangements 39-46, comprisinga saturation indicator supported by the dressing member configured toprovide a visual indication of a level of liquid saturation beneath thebacking layer.

49. A wound dressing kit for reduced pressure wound therapy, comprising:

-   -   a pump assembly;    -   a power source configured to provide a source of power to at        least the pump assembly; and    -   a dressing member having a fluid impermeable backing layer;    -   wherein:        -   the pump assembly is supported by the dressing member; and        -   the power source is supported by a separate support member            and is positionable in a remote position spaced apart from            the dressing member.

50. The wound dressing kit of Arrangement 49, wherein the dressingmember comprises one or more absorptive layers and a fluid impermeablebacking layer over the one or more absorptive layers, wherein the pumpassembly is supported adjacent to one or more of the absorptive layers.

51. The wound dressing kit of any one of Arrangements 49-50, wherein thepump assembly comprises a voice coil actuated pump.

52. The wound dressing kit of any one of Arrangements 49-51, comprisinga pull tab, button, conductive label, or switch configured to activatethe power source.

53. The wound dressing kit of any one of Arrangements 49-52, comprisinga pressure indicator supported by the dressing member configured toprovide a visual indication of a level of pressure beneath the backinglayer.

54. The wound dressing kit of any one of Arrangements 49-53, comprisinga saturation indicator supported by the dressing member configured toprovide a visual indication of a level of liquid saturation beneath thebacking layer.

55. The wound dressing kit of Arrangements 49-54 or any one of theprevious arrangements, comprising a viewing window in an opaque backinglayer, the viewing window being configured to permit a user to determinea level of saturation within the dressing member.

56. A wound dressing kit for reduced pressure wound therapy, comprising:

-   -   a dressing member having a fluid impermeable backing layer, a        transmission layer, and an absorption layer between the        transmission layer and the backing layer; and    -   a pump assembly positioned within an opening formed in the        absorption layer sized and configured such that the pump        assembly is positioned in direct contact with the transmission        layer.

57. The wound dressing kit of Arrangement 56, wherein the pump has aport that is in direct fluid communication with the transmission layer,such that negative pressure is applied by the pump assembly directly tothe transmission layer.

58. The wound dressing kit of any one of Arrangements 56-57, furthercomprising a liquid barrier or liquid filter in communication with thepump assembly and configured to prevent the passage of liquid into thepump.

59. The wound dressing kit of any one of Arrangements 56-58, wherein theopening does not extend into the transmission layer.

60. The wound dressing kit of any one of Arrangements 56-59, wherein theopening extends through the transmission layer.

61. The wound dressing kit of any one of Arrangements 56-60, furthercomprising an impermeable film between the absorption layer and thetransmission layer, the impermeable film having an opening therein incommunication with a port in the pump assembly configured to permit thepassage of negative pressure from the pump assembly into thetransmission layer.

62. The wound dressing kit of any one of Arrangements 56-61, wherein thepump assembly is configured to transfer liquid from the transmissionlayer through the pump into the absorption layer.

63. The wound dressing kit of any one of Arrangements 56-62, wherein thepump assembly is covered by the backing layer.

64. The wound dressing kit of Arrangements 63, further comprising a venthole in the backing layer configured to permit exhaust air from the pumpassembly to pass through the backing layer.

65. The wound dressing kit of any one of Arrangements 56-64, wherein thepump assembly comprises a voice coil actuated pump.

66. The wound dressing kit of any one of Arrangements 56-64, comprisinga pull tab, button, conductive label, or switch configured to activatethe power source.

67. The wound dressing kit of any one of Arrangements 56-66, comprisinga pressure indicator supported by the dressing member configured toprovide a visual indication of a level of pressure beneath the backinglayer.

68. The wound dressing kit of any one of Arrangements 56-67, comprisinga saturation indicator or sensor supported by the dressing memberconfigured to provide a visual indication of a level of liquidsaturation beneath the backing layer.

69. The wound dressing kit of Arrangement 68, wherein the saturationindicator or sensor is positioned adjacent to the pump assembly.

70. The wound dressing kit of any one of Arrangements 56-69, furthercomprising a power source configured to provide a source of power to atleast the pump assembly.

71. The wound dressing kit of any one of Arrangements 56-70, wherein thebacking layer is opaque, and comprising one or more viewing windows inthe backing layer configured to permit a user to determine a level ofsaturation within the dressing member.

72. A method of treating a wound, comprising;

-   -   placing a wound dressing kit of any one of the previous        arrangements over a wound;    -   applying negative pressure to the wound from the pump assembly.

BRIEF DESCRIPTION OF THE DRAWINGS

Embodiments of the present disclosure will now be described hereinafter,by way of example only, with reference to the accompanying drawings inwhich:

FIGS. 1A-B illustrate an embodiment of a dressing kit for negativepressure wound therapy.

FIGS. 2A-C illustrate additional embodiments of a dressing kit fornegative pressure wound therapy.

FIGS. 3A-C illustrate additional embodiments of a dressing kit fornegative pressure wound therapy.

FIGS. 4A-C illustrate additional embodiments of dressing kits fornegative pressure wound therapy, showing two different exemplifyingsizes of such embodiment.

FIGS. 5A-B illustrate additional embodiments of a dressing kit fornegative pressure wound therapy, showing two different exemplifyingsizes of such embodiment.

FIGS. 6A-B illustrate additional embodiments of a dressing kit fornegative pressure wound therapy.

FIGS. 7A-B illustrate additional embodiments of a dressing kit fornegative pressure wound therapy, showing two different exemplifyingsizes of such embodiment.

FIGS. 8A-B illustrate additional embodiments of a dressing kit fornegative pressure wound therapy, showing two different exemplifyingsizes of such embodiment.

FIGS. 9A-B illustrate additional embodiments of a dressing kit fornegative pressure wound therapy, showing two different exemplifyingsizes of such embodiment.

FIGS. 10A-C illustrate additional embodiments of a dressing kit fornegative pressure wound therapy, showing such dressing kit schematicallyin section, isometrically, and in a top view, respectively.

FIGS. 11A-C illustrate additional embodiments of a dressing kit fornegative pressure wound therapy, showing such dressing kit schematicallyin section, isometrically, and in a top view, respectively.

FIGS. 12A-B illustrate additional embodiments of a dressing kit fornegative pressure wound therapy, showing such dressing kit schematicallyin section and isometrically.

FIGS. 13A-B illustrate additional embodiments of a dressing kit fornegative pressure wound therapy, showing such dressing kit schematicallyin section and isometrically.

FIGS. 14A-14D illustrate additional embodiments of a dressing kit fornegative pressure wound therapy.

FIG. 15 illustrates an additional embodiment of a dressing kit fornegative pressure wound therapy.

FIG. 16 illustrates an additional embodiment of a dressing kit fornegative pressure wound therapy.

FIG. 17 illustrates an additional embodiment of a dressing kit fornegative pressure wound therapy.

FIGS. 18A-C illustrate additional embodiments of a dressing kit fornegative pressure wound therapy.

FIGS. 19A-C illustrate additional embodiments of a dressing kit fornegative pressure wound therapy.

FIG. 20 illustrates an additional embodiment of a dressing kit fornegative pressure wound therapy.

FIGS. 21A-21C illustrate an additional embodiment of a dressing kit fornegative pressure wound therapy.

FIGS. 22A-C illustrate an additional embodiment of a dressing kit fornegative pressure wound therapy.

FIGS. 23A-C illustrate an additional embodiment of a dressing kit fornegative pressure wound therapy.

FIGS. 24A-F illustrate an additional embodiment of an activation switchof a dressing kit for negative pressure wound therapy.

FIGS. 25A-B illustrate an additional embodiment of a dressing kit fornegative pressure wound therapy.

FIGS. 26A-G illustrate additional embodiments of a dressing kit fornegative pressure wound therapy.

FIGS. 27A-D illustrate additional embodiments of a dressing kit fornegative pressure wound therapy.

FIGS. 28A-G illustrate additional embodiments of a dressing kit fornegative pressure wound therapy.

FIGS. 29A-B illustrate additional embodiments of a dressing kit fornegative pressure wound therapy.

FIG. 30 illustrates an additional embodiment of a dressing kit fornegative pressure wound therapy.

FIG. 31 illustrates additional embodiments of a dressing kit fornegative pressure wound therapy.

FIGS. 32A-B illustrate an additional embodiment of a dressing kit fornegative pressure wound therapy.

FIGS. 33A-E illustrate additional embodiments of a dressing kit fornegative pressure wound therapy.

FIGS. 34A-C illustrate additional embodiments of a dressing kit fornegative pressure wound therapy.

FIGS. 35A-B illustrate additional embodiments of a dressing kit fornegative pressure wound therapy.

FIGS. 36A-B illustrate an additional embodiment of a dressing kit fornegative pressure wound therapy.

FIGS. 37A-B illustrate an additional embodiment of a dressing kit fornegative pressure wound therapy.

FIG. 38 illustrates an additional embodiment of a dressing kit fornegative pressure wound therapy.

FIG. 39 illustrates an additional embodiment of a dressing kit fornegative pressure wound therapy.

FIG. 40 illustrates an additional embodiment of a dressing kit fornegative pressure wound therapy.

FIGS. 41A-C illustrate an additional embodiment of a dressing kit fornegative pressure wound therapy.

FIG. 42 illustrates an additional embodiment of a dressing kit fornegative pressure wound therapy.

FIGS. 43A-E illustrate additional embodiments of a dressing kit fornegative pressure wound therapy.

FIGS. 44A-B illustrate additional embodiments of a dressing kit fornegative pressure wound therapy.

FIGS. 45A-C illustrate additional embodiments of a dressing kit fornegative pressure wound therapy.

FIG. 46 illustrates an additional embodiment of a dressing kit fornegative pressure wound therapy.

FIGS. 47A-B illustrate an additional embodiment of a dressing kit fornegative pressure wound therapy.

FIGS. 48A-B illustrate an additional embodiment of a dressing kit fornegative pressure wound therapy.

FIG. 49 illustrates an embodiment of a switch or activation mechanism.

FIGS. 50A-D illustrate an embodiment of a switch or activationmechanism.

FIGS. 51A-B illustrate an additional embodiment of a dressing kit fornegative pressure wound therapy.

FIGS. 52A-C illustrate an additional embodiment of a dressing kit fornegative pressure wound therapy.

FIGS. 53A-B illustrate an additional embodiment of an activation switchof a dressing kit for negative pressure wound therapy.

FIGS. 54A-C illustrate an additional embodiment of an activation switchof a dressing kit for negative pressure wound therapy.

FIG. 55 illustrates an additional embodiment of an activation switch ofa dressing kit for negative pressure wound therapy.

FIGS. 56A-B illustrate an additional embodiment of an indicator light ofa dressing kit for negative pressure wound therapy.

FIG. 57 illustrates an additional embodiment of an activation switch ofa dressing kit for negative pressure wound therapy.

FIGS. 58A-C illustrate an additional embodiment of an activation switchof a dressing kit for negative pressure wound therapy.

FIG. 59 illustrates an additional embodiment of an activation switch ofa dressing kit for negative pressure wound therapy.

FIG. 60 illustrates an additional embodiment of an activation switch ofa dressing kit for negative pressure wound therapy.

FIGS. 61A-B illustrate an additional embodiment of an activation switchof a dressing kit for negative pressure wound therapy.

FIG. 62 illustrates an additional embodiment of an activation switch ofa dressing kit for negative pressure wound therapy.

FIG. 63 illustrates an additional embodiment of a dressing kit fornegative pressure wound therapy.

FIGS. 64A-B illustrate an additional embodiment of a dressing kit fornegative pressure wound therapy.

FIGS. 65A-B illustrate several embodiments of a pressure indicator of adressing kit for negative pressure wound therapy.

FIGS. 66A-C illustrate additional embodiments of a dressing kit fornegative pressure wound therapy.

FIGS. 67-70 illustrate additional embodiments of dressing kits fornegative pressure wound therapy having one or more indicator lightsthereon.

FIGS. 71A-72D illustrate additional embodiments of a dressing kit fornegative pressure wound therapy having one or more pressure indicatorsthereon.

FIGS. 73-74 illustrate additional embodiments of a dressing kit fornegative pressure wound therapy.

FIGS. 75-77 illustrate additional embodiments of a dressing kit fornegative pressure wound therapy having one or more fill indicatorsthereon.

FIG. 78 illustrates an additional embodiment of a dressing kit fornegative pressure wound therapy.

FIGS. 79A-B illustrate an additional embodiment of an activation switchand/or pressure indicator for a dressing kit for negative pressure woundtherapy.

FIGS. 80A-B illustrate an additional embodiment of a pressure indicatorfor a dressing kit for negative pressure wound therapy.

FIGS. 81A-B illustrate an additional embodiment of a dressing kit fornegative pressure wound therapy having one or more pressure indicatorsthereon.

FIGS. 82A-B illustrate an additional embodiment of a dressing kit fornegative pressure wound therapy.

FIGS. 83A-C illustrate an additional embodiment of a dressing kit fornegative pressure wound therapy.

FIGS. 84A-B illustrate an additional embodiment of a portion of adressing kit supporting or housing the pump assembly.

FIGS. 85A-E illustrate an additional embodiment of a dressing kit fornegative pressure wound therapy.

DETAILED DESCRIPTION OF SOME EXEMPLIFYING EMBODIMENTS

Embodiments disclosed herein relate to apparatuses and methods oftreating a wound with reduced pressure. It will be understood thatembodiments of the present disclosure are generally applicable to use intopical negative pressure (“TNP”) therapy systems. Briefly, negativepressure wound therapy assists in the closure and healing of many formsof “hard to heal” wounds by reducing tissue oedema, encouraging bloodflow and granular tissue formation, and/or removing excess exudate andcan reduce bacterial load (and thus infection risk). In addition, thetherapy allows for less disturbance of a wound leading to more rapidhealing. TNP therapy systems can also assist in the healing ofsurgically closed wounds by removing fluid and by helping to stabilizethe tissue in the apposed position of closure. A further beneficial useof TNP therapy can be found in grafts and flaps where removal of excessfluid is important and close proximity of the graft to tissue isrequired in order to ensure tissue viability.

As is used herein, reduced or negative pressure levels, such as −X mmHg,represent pressure levels that are below standard atmospheric pressure,which corresponds to 760 mmHg (or 1 atm, 29.93 inHg, 101.325 kPa, 14.696psi, etc.). Accordingly, a negative pressure value of −X mmHg reflectsabsolute pressure that is X mmHg below 760 mmHg or, in other words, anabsolute pressure of (760−X) mmHg. In addition, negative pressure thatis “less” or “smaller” than X mmHg corresponds to pressure that iscloser to atmospheric pressure (e.g., −40 mmHg is less than −60 mmHg).Negative pressure that is “more” or “greater” than −X mmHg correspondsto pressure that is further from atmospheric pressure (e.g., −80 mmHg ismore than −60 mmHg).

Any of the wound dressing embodiments disclosed herein can be locatedover a wound site to be treated. The dressing can form a substantiallysealed cavity or enclosure over the wound site. It will be appreciatedthat throughout this specification reference is made to a wound. In thissense it is to be understood that the term wound is to be broadlyconstrued and encompasses open and closed wounds in which skin is torn,cut or punctured or where trauma causes a contusion, or any othersurficial or other conditions or imperfections on the skin of a patientor otherwise that benefit from reduced pressure treatment. A wound isthus broadly defined as any damaged region of tissue where fluid may ormay not be produced. Examples of such wounds include, but are notlimited to, acute wounds, chronic wounds, surgical incisions and otherincisions, subacute and dehisced wounds, traumatic wounds, flaps andskin grafts, lacerations, abrasions, contusions, burns, diabetic ulcers,pressure ulcers, stoma, surgical wounds, trauma and venous ulcers or thelike. In some embodiments, the components of the TNP system describedherein can be particularly suited for incisional wounds that exude asmall amount of wound exudate.

In any of the apparatus embodiments disclosed herein, as in theembodiment illustrated in FIG. 1, the pump assembly can be acanisterless pump assembly (meaning that the pump assembly does not havean exudate or liquid collection canister). However, any of the pumpembodiments disclosed herein can be configured to include or support acanister. Additionally, in any of the apparatus embodiments disclosedherein, any of the pump assembly embodiments can be mounted to orsupported by the dressing, or adjacent to the dressing. Additionally, inany of the apparatus embodiments disclosed herein, the pump assembly canhave two or more pumps and one, two, or more power sources. In any ofthe embodiments disclosed herein, the pump assembly, power source, andor any support member or film supporting or covering the pump assemblyor power source can have any of a variety of colors used to match aperson's skin including any tone or coloring thereof. Further, in anyembodiments disclosed herein, the pump assembly can have any of thecomponents, features, or other details of any of the pump assemblyembodiments disclosed in U.S. patent application Ser. No. 13/287,897(titled “REDUCED PRESSURE THERAPY APPARATUSES AND METHODS OF USINGSAME), filed on Nov. 2, 2011, which disclosure is hereby incorporated byreference as if fully set forth herein.

Any of the wound dressing embodiments disclosed herein can be arrangedor configured to operate without the use of an exudate canister. Anydressing embodiments can be configured to have a film having a highwater vapour permeability to enable the evaporation of surplus fluid,and can have a superabsorbing material contained therein to safelyabsorb wound exudate. Some embodiments of the apparatus are designed forsingle-use therapy and can be disposed of in an environmentally friendlymanner after an approximately maximum usage of from seven to elevendays. Some embodiments of the pump are designed for an operation periodof up to fourteen days, and some for up to twenty days. The pump can beprogrammed to automatically terminate therapy after a desired number ofdays, e.g., after seven days, further operation of the pump will not bepossible. Some embodiments are designed for longer or repeated usage,and can be configured to support an exudate canister.

In any dressing kit embodiments, including without limitation theillustrated embodiments, the pump assembly can be of a sufficientlysmall and portable size to be supported on or adjacent to the dressing,or on another location of a user's body or in a user's clothing. Forexample and without limitation, as will be described in greater detailbelow, in any of the embodiments disclosed herein, the pump assembly canbe attached to a specially formed depression or space on the dressing,can be embedded within, supported on top of or adjacent to one or moreabsorbent or other dressing layers, or can be otherwise supported by thedressing. Additionally, in any embodiments disclosed or incorporated byreference herein (collectively referred to as “disclosed herein”), thepump assembly can be sized to be attached using adhesive medical tape orotherwise to a person's skin in a comfortable location, adjacent to oron the dressing or otherwise, or can be sized to fit within a person'spants or shirt pocket or tethered to a person's body using a lanyard,pouch, or other suitable device or article.

Any of the dressing kit embodiments disclosed herein can be manufacturedin a wide variety of different models or versions, wherein the size ofthe dressing can be varied to accommodate a wide range of wound sizes.For example, any of the dressing kits can be made having the followingsizes of dressings and wound pads or other absorbent elements. In anyembodiments disclosed herein, the size of the dressing or the wound padcan be defined by the area of the dressing or the wound pad, wherein thespecific length and width (if rectangular) can be varied to accommodatea wider range of wound sizes. For example, the dressings and/or woundpads can be rectangular, circular, ovular, triangular, pentagonal,hexagonal, trapezoidal, or otherwise. The shape and dimensions of thevarious dressings and wound pads can fall within any of the area rangeslisted below, otherwise disclosed in this application, or otherwise.Thus, the dressing dimensions and shapes are not limited to thosespecified in this disclosure but can be any suitable size and shape.

Approximate Approximate Approximate Wound Approximate Dressing SizeDressing Size Pad Size Wound Pad Size (Dimensions) (Area) (Dimensions)(Area) 10 cm × 30 cm 300 cm² 5 cm × 20 cm 100 cm² (4 in × 11.75 in) (47in²) (2 in × 8 in) (16 in²) 15 cm × 15 cm 225 cm² 10 cm × 10 cm 100 cm²(6 in × 6 in) (36 in²) (4 in × 4 in) (16 in²) 15 cm × 20 cm 300 cm² 10cm × 15 cm 150 cm² (6 in × 8 in) (48 in²) (4 in × 6 in) (24 in²) 10 cm ×20 cm 200 cm² 5 cm × 10 cm 50 cm² (4 in × 8 in) (32 in²) (2 in × 4 in)(8 in²) 20 cm × 20 cm 400 cm² 15 cm × 15 cm 225 cm² (8 in × 8 in) (64in²) (6 in × 6 in) (36 in²)

In any embodiments disclosed herein, the dressing can be sized such thatthe pad or absorptive portion of the dressing is approximately 50×100mm, 100×150 mm, 100×250 mm, or any size within these ranges. Someembodiments of the dressing can be configured to be universal, so thatone dressing size, shape, and configuration can be adhered to the hips,arms, thighs, torso, back, and/or other body parts.

Some embodiments of the overlay or dressing can be substantiallyimpervious to air flow and the flow of bacteria or other contaminantsthrough the overlay layer, while being pervious to vapor transmission.

As described in greater detail in U.S. patent application Ser. No.13/092,042, which is hereby incorporated by reference in its entirety asif fully set forth herein, in any of the dressing embodiments disclosedherein, a layer of absorbent material can be provided above thetransmission layer. The absorbent material which can be a foam ornon-woven natural or synthetic material and can optionally include or besuper-absorbent material that can form a reservoir for fluid,particularly liquid, removed from the wound site and draws those fluidstowards a cover layer. The material of the absorbent layer can preventliquid collected in the wound dressing from flowing in a sloshingmanner. The absorbent layer can also help distribute fluid throughoutthe layer via a wicking action so that fluid is drawn from the woundsite and stored throughout the absorbent layer. This helps preventagglomeration in areas of the absorbent layer. The capacity of theabsorbent material must be sufficient to manage the exudates flow rateof a wound when negative pressure is applied. Since in use the absorbentlayer experiences negative pressure, the material of the absorbent layercan be selected to absorb liquid. A number of materials exist that areable to absorb liquid when under negative pressure, for examplesuperabsorber material. For example and without limitation, anyembodiments of the absorbent layer can be manufactured using ALLEVYN™foam, Freudenberg 114-224-4 and/or Chem-Posite™11C-450, or any othersuitable material. Other materials may be more appropriate for and canbe used in and of the dressing embodiments disclosed herein. Suitablesuperabsorbers can have polyacrylate or carbomethoxycellulose basedmaterials in the form of granules or fibers or combinations thereof.

In any embodiments disclosed herein, the absorbent layer can be a layerof non-woven cellulose fibers having super-absorbent material in theform of dry particles dispersed throughout. In some arrangements, theuse of natural and/or synthetic fibres such as cotton, cellulose andviscose fibres can introduce fast wicking elements which help quicklyand evenly distribute liquid taken up by the dressing. The juxtapositionof multiple strand-like fibers leads to strong capillary action in thefibrous pad which helps distribute liquid. In this way, thesuper-absorbent material is efficiently supplied with liquid. Also, allregions of the absorbent layer are provided with liquid.

The wicking action can also assist in bringing liquid into contact withthe upper cover layer to aid increase transpiration rates of thedressing. The wicking action can also assist in delivering liquiddownward towards the wound bed when exudation slows or halts. Thisdelivery process helps maintain the transmission layer and lower woundbed region in a moist state which helps prevent crusting within thedressing. Crusting could lead to blockage both within the dressinglayers or components beneath the cover or backing layer, and also withinthe port and/or conduit which can inhibit the flow of wound fluids inthe dressing and also inhibit a flow of reduced pressure to the wound orportions of the wound. Thus, the delivery process can help maintain anenvironment optimized for wound healing.

A layer of porous material can be located above the wound contact layer.This porous layer, or transmission layer, allows transmission of fluidincluding liquid and gas away from a wound site into upper layers of thewound dressing. In particular, the transmission layer can ensure that anopen air channel can be maintained to communicate negative pressure overthe wound area even when the absorbent layer has absorbed substantialamounts of exudates. The layer should remain open under the typicalpressures that will be applied during negative pressure wound therapy asdescribed above, so that the whole wound site sees an equalized negativepressure. The layer can be formed of a material having a threedimensional structure. For example, a knitted or woven spacer fabric(for example Baltex 7970 weft knitted polyester) or a non-woven fabriccan be used. Other materials can be utilized, and examples of suchmaterials are described in U.S. patent application Ser. No. 13/092,042,which are hereby incorporated by reference and made part of thisdisclosure.

In any embodiments disclosed herein, the transmission layer can have a3D polyester spacer fabric layer, such as with any embodiments of thedressing disclosed in U.S. Patent Application Publication No.2011/0282309 (Ser. No. 13/092,042), (titled WOUND DRESSING AND METHOD OFUSE), filed Apr. 21, 2011, which application is hereby incorporated byreference as if fully set forth herein. Some embodiments of thetransmission layer can have a top layer (that is to say, a layer distalfrom the wound-bed in use) which is a 84/144 textured polyester (whichcan be approximately 24.5%, or from approximately 22% to approximately27% in terms of material composition), and a bottom layer (i.e., a layerwhich lies proximate to the wound bed in use) which can be a 100 denierflat polyester (which can be approximately 31.4%, or from approximately28% to approximately 34% in terms of material composition), and a thirdlayer formed sandwiched between these two layers which is a regiondefined by a knitted polyester viscose, cellulose or the likemonofilament fiber (which can be approximately 44.1%, or fromapproximately 40% to approximately 48% in terms of materialcomposition). Other suitable materials and other linear mass densitiesof fiber can be used.

Additionally, any embodiments of the transmission layer can be formedusing any of the following needle arrangement parameters.

Needle Arrangement Dial Set Out F1 F2 F3 F4 F5 F6 F7 F8 F9 F10 F11 F12TA AW KA WA AW TA WB TB TB KB Pattern area: 4 wales x 12 courses F12 K KK K F11 W W W W F10 W T W T F9 K K K K F8 W W W W F7 T W K W F6 K K K KF5 W W W W F4 W T W T F3 K K K K F2 W W W W F1 T W T W

This differential between filament counts in the spaced apart layershelps control moisture flow across the transmission layer. Particularly,by having a filament count greater in the top layer, that is to say, thetop layer is made from a yarn having more filaments than the yarn usedin the bottom layer, liquid tends to be wicked along the top layer morethan the bottom layer. In use, this differential tends to draw liquidaway from the wound bed and into a central region of the dressing wherethe absorbent layer helps lock the liquid away or itself wicks theliquid onwards towards the cover layer where it can be transpired.

Material Layer Composition

Preferably, to improve the liquid flow across the transmission layer(that is to say perpendicular to the channel region formed between thetop and bottom spacer layers, the 3D fabric is treated with a drycleaning agent (such as, but not limited to, Perchloro Ethylene) to helpremove any manufacturing products such as mineral oils, fats and/orwaxes used previously which might interfere with the hydrophiliccapabilities of the transmission layer. In some embodiments, anadditional manufacturing step can subsequently be carried in which the3D spacer fabric is washed in a hydrophilic agent (such as, but notlimited to, Feran Ice 30 g/l available from the Rudolph Group). Thisprocess step helps ensure that the surface tension on the materials isso low that liquid such as water can enter the fabric as soon as itcontacts the 3D knit fabric. This also aids in controlling the flow ofthe liquid insult component of any exudates.

In some embodiments, the absorbent layer can be an air-laid material.Heat fusible fibers can optionally be used to assist in holding thestructure of the pad together. It will be appreciated that rather thanusing super-absorbing particles or in addition to such use,super-absorbing fibers can be utilized according to some embodiments ofthe present invention. An example of a suitable material is the ProductChem-Posite™ 11 C available from Emerging Technologies Inc (ETi) in theUSA.

Optionally, the absorbent layer can include synthetic stable fibersand/or bi-component stable fibers and/or natural stable fibers and/orsuper-absorbent fibers. Fibers in the absorbent layer can be securedtogether by latex bonding or thermal bonding or hydrogen bonding or acombination of any bonding technique or other securing mechanism. In anyembodiments disclosed herein, the absorbent layer can be formed byfibers which operate to lock super-absorbent particles within theabsorbent layer. This helps ensure that super-absorbent particles do notmove external to the absorbent layer and towards an underlying woundbed. This is particularly helpful because when negative pressure isapplied there is a tendency for the absorbent pad to collapse downwardsand this action would push super-absorbent particle matter into adirection towards the wound bed if they were not locked away by thefibrous structure of the absorbent layer.

The absorbent layer can comprise a layer of multiple fibers. Preferably,the fibers are strand-like and made from cellulose, polyester, viscoseor the like. Preferably, dry absorbent particles are distributedthroughout the absorbent layer ready for use. In any embodimentsdisclosed herein, the absorbent layer can have a pad of cellulose fibersand a plurality of super absorbent particles. In additional embodiments,the absorbent layer is a non-woven layer of randomly orientatedcellulose fibers.

Super-absorber particles/fibers can be, for example, sodium polyacrylateor carbomethoxycellulose materials or the like or any material capableof absorbing many times its own weight in liquid. In some embodiments,the material can absorb more than five times its own weight of 0.9% W/Wsaline, etc., or more than 15 times its own weight of 0.9% W/W saline,etc., or, in some embodiments, more than 20 times its own weight of 0.9%W/W saline, etc. Preferably, the material is capable of absorbing morethan 30 times its own weight of 0.9% W/W saline, etc. The absorbentlayer can have one or more through holes located so as to underlie asuction port. In any embodiments disclosed herein, a hydrophobic filteror other filter or object configured to permit the flow of air or gasthrough the port or openings in the dressing and prevent the flow ofliquid or solids through the port or openings in the dressing can bepositioned upstream of the pump to prevent any liquids or solids fromentering the pump.

In some embodiments, the wound site can be filled partially orcompletely with a wound packing material. Deeper wounds can benefit fromsuch packing material. The wound packing material can be used inaddition to the wound dressing, or can be integral to the wounddressing. The wound packing material generally can comprise a porous andconformable material, for example foam (including reticulated foams),and gauze. Preferably, the wound packing material is sized or shaped tofit within the wound site so as to fill any empty spaces. The wounddressing can then be placed over the wound site and wound packingmaterial overlying the wound site. When a wound packing material isused, once the wound dressing is sealed over the wound site, TNP istransmitted from a pump through the wound dressing, through the woundpacking material, and to the wound site. This negative pressure drawswound exudate and other fluids or secretions away from the wound site.

The dressing of any dressing kit embodiments disclosed herein can have agas impermeable, but moisture vapor permeable, cover layer extendingacross the width of the wound dressing. The cover layer, which can forexample be a polyurethane film (for example, Elastollan SP9109) or anyother suitable material having a pressure sensitive adhesive on oneside, is substantially gas impermeable, thereby creating a substantiallysealed enclosure over the wound. In this way an effective chamber ismade between the cover layer and a wound site where a negative pressurecan be established. The cover layer can be sealed to the wound contactlayer in a border region around the circumference of the dressing,ensuring that no air is drawn in through the border area, for examplevia adhesive or welding techniques. The cover layer can protect thewound from external bacterial contamination (bacterial barrier) andallows liquid from wound exudates to be transferred through the layerand evaporated from the film outer surface. The cover layer can have apolyurethane film and an adhesive pattern spread onto the film. Thepolyurethane film is moisture vapor permeable and can be manufacturedfrom a material that has an increased water transmission rate when wet.

An orifice can be provided in the cover film to allow a negativepressure to be applied to the dressing. As mentioned, in someembodiments, a suction port can be sealed to the top of the cover filmover the orifice, which can communicate negative pressure through theorifice, or the pump assembly can be mounted directly over the orifice.The port or pump assembly can be adhered and sealed to the cover filmusing an adhesive such as an acrylic, cyanoacrylate, epoxy, UV curableor hot melt adhesive. If used, the port can be formed from a softpolymer, for example a polyethylene, a polyvinyl chloride, a silicone orpolyurethane having a hardness of 30 to 90 on the Shore A scale.

The dressing can have a filter element that is impermeable to liquids,but permeable to gases. The filter element can act as a liquid barrier,to substantially prevent or inhibit liquids from escaping from the wounddressing, as well as an odor barrier. The filter element can alsofunction as a bacterial barrier. In some embodiments, the pore size ofthe filter element can be approximately 0.2 μm. Suitable materials forthe filter material of the filter element include 0.2 micron Gore™expanded PTFE from the MMT range, PALL Versapore™ 200R, and Donaldson™TX6628. The filter element thus enables gas to be exhausted through theorifice. Liquid, particulates and pathogens however are contained in thedressing. Other details regarding the filter are disclosed in U.S.patent application Ser. No. 13/092,042 (2011/0282309) and incorporatedby reference herein.

The wound dressing and its methods of manufacture and use as describedherein may also incorporate features, configurations and materialsdescribed in the following patents and patent applications, each ofwhich is incorporated by reference in their entireties herein as if madepart of this disclosure: U.S. Pat. Nos. 7,524,315, 7,708,724, 7,909,805;7,964,766; 8,062,272; 8,080,702, 8,105,295, 8,282,611, and 8,303,552;U.S. Patent Application Publication Nos. 2009/0254054, 2010/0160880,2010/0274207, 2011/0009838, 2011/0028918, 2011/0054421, 2011/0054423,and 2011/0118683, as well as U.S. application Ser. Nos. 29/389,782,filed Apr. 15, 2011, and 29/389,783, filed Apr. 15, 2011. From theseincorporated by reference patents and patent applications, features,configurations, materials and methods of manufacture or use for similarcomponents to those described in the present disclosure can besubstituted, added or implemented into embodiments of the presentapplication.

In operation, the wound dressing can be sealed over a wound site forminga wound cavity. The pump assembly can provide a source of a negativepressure to the dressing. Fluid can be drawn toward the orifice throughthe wound dressing from a wound site below the wound contact layer. Thefluid can move towards the orifice through the transmission layer. Asthe fluid is drawn through the transmission layer, wound exudate can beabsorbed into the absorbent layer.

The general shape of the wound dressing can be square, ovular,rectangular, or otherwise. The dressing can have rounded corner regions.It will be appreciated that wound dressings according to otherembodiments of the present invention can be shaped differently such assquare, circular or elliptical dressings, or the like.

The desired size of the wound dressing can be selected based on the sizeand type of wound it will be used in. In any embodiments, though notrequired, the wound dressing can measure between 20 and 40 cm on itslong axis, and between 10 to 25 cm on its short axis. For example,dressings can be provided in sizes of approximately 10×20 cm, 10×30 cm,10×40 cm, 15×20 cm, and 15×30 cm, or any other sizes within these rangesor otherwise.

Whilst some embodiments of the present invention have so far beendescribed in which the transmission layer is formed as a 3D knit layer,e.g., two layers spaced apart by a monofilament layer, it will beappreciated that some embodiments of the present invention are notrestricted to the use of such a material. In some embodiments, as analternative to such a 3D knit material, one or more layers of a widevariety of materials could be utilized. In each case, according toembodiments of the present invention, the openings presented by layersof the transmission layer are wider and wider as one moves away from theside of the dressing which, in use will be located proximate to thewound. In any embodiments disclosed herein, the transmission layer canbe provided by multiple layers of open celled foam. Though noterequired, the foam can be reticulated open cell foam. The foam can behydrophilic or able to wick aqueous based fluids. The pore size in eachlayer is selected so that in the foam layer most proximate to the woundside in use the pores have a smallest size. If only one further foamlayer is utilized that includes pore sizes which are greater than thepore sizes of the first layer. This helps avoid solid particulate beingtrapped in the lower layer which thus helps maintain the lower layer inan open configuration in which it is thus able to transmit airthroughout the dressing. In any embodiments disclosed herein, two,three, four or more foam layers can be included. The foam layers can beintegrally formed, for example, by selecting a foam having a large poresize and then repeatedly dipping this to a lesser and lesser extent intomaterial which will clog the pores or alternatively, the transmissionlayer formed by the multiple foam layers can be provided by laminatingdifferent types of foam in a layered arrangement or by securing suchlayers of foam in place in a known manner.

Some embodiments of the dressing can be configured to permit therepositionability of the dressing. In any embodiments disclosed herein,the dressing can have a wound contact surface that is covered with anadhesive, such as a silicone based adhesive. As described in U.S. patentapplication Ser. No. 13/092,042, which disclosure is hereby incorporatedby reference as if fully set forth herein, though not required, a lowersurface of any of the wound dressing embodiments disclosed herein canhave an optional wound contact layer. Any of the dressing embodimentsdisclosed herein can be made without the wound contact layer. The woundcontact layer can be a polyurethane layer or polyethylene layer or otherflexible layer which can be made porous or perforated, for example via ahot pin process, laser ablation process, ultrasound process or in someother way or otherwise made permeable to liquid and gas. Theperforations can enable fluid and/or gas to flow through the layer. Thewound contact layer can help prevent tissue ingrowth into the othermaterial of the wound dressing.

The perforations of the contact layer can be sized small enough to meetthis requirement but still allow fluid through. For example, the contactlayer can have perforations formed as slits or holes having a sizeranging from approximately 0.025 mm to approximately 1.8 mm, or fromapproximately 1.2 mm to approximately 1.8 mm, which are considered smallenough to help prevent tissue ingrowth into the wound dressing whileallowing wound exudate to flow into the dressing. In any embodiments,therefore, the perforations can be formed as holes ranging in diameterfrom approximately 1.2 mm to approximately 2.8 mm, or from approximately1.2 mm to approximately 1.8 mm. The hole spacing or density in anyembodiments can be approximately 8 holes/cm², or from approximately 6holes/cm² to approximately 10 holes/cm². As used throughout thisdisclosure, unless otherwise defined, the term approximately can be usedto describe a range of +/−10% of the stated value. Additionally, in anyembodiments of the contact layer, the holes can be formed atapproximately a 3.655 mm triangular pitch. Any of the wound contactlayer embodiments disclosed herein can be formed from silicone.

The wound contact layer can help hold the whole wound dressing togetherand help to create an air tight seal around the absorbent pad in orderto maintain negative pressure at the wound. The wound contact layer alsoacts as a carrier for an optional lower and upper adhesive layer (notshown). For example, a lower pressure sensitive adhesive can be providedon the underside surface of the wound dressing whilst an upper pressuresensitive adhesive layer can be provided on the upper surface of thewound contact layer. The pressure sensitive adhesive, which can be asilicone, hot melt, hydrocolloid or acrylic based adhesive or other suchadhesives, can be formed on both sides or optionally on a selected oneor none of the sides of the wound contact layer. When a lower pressuresensitive adhesive layer is utilized, this helps adhere the wounddressing to the skin around a wound site.

As mentioned, any dressing embodiments for use in the dressing kitsdisclosed or incorporated by reference herein can have an adhesivecovered bottom (e.g., wound contacting) surface. In any embodimentsdisclosed herein, as mentioned, the adhesive can be a silicone adhesiveincluding, for example, polysiloxanes or polyorganosiloxanes or otherpolymeric pressure sensitive silicone adhesives. For example,polydimethylsiloxane or the like can be used. The adhesive formulationcan be a mixture of alkyl pendant siloxanes, which can be spread andcast as a two part mix with a catalyst such that a final polymerisationstep takes place following casting or spreading. In any embodimentsdisclosed herein, a dressing layer can have a non-perforated siliconeadhesive coating (coat weight 130 gsm nominal) and full spread acrylicadhesive (27 to 37 gsm) coated onto opposite sides of an extruded EU30polyurethane clear film (27 to 37 gsm). Moisture vapour permeability ofsuch an arrangement can be between approximately 367 gm⁻²/24 hrs toapproximately 405 gm⁻²/24 hrs, or a mean moisture vapour permeability of382 gm⁻²/24 hrs.

Some embodiments or arrangements of a silicone adhesive layer suitablefor dressing embodiments disclosed herein can have a moisture vapourtransmission rate between approximately 350 gm⁻²/24 hrs andapproximately 410 gm⁻²/24 hrs. Aptly, the average moisture vapourpermeability of some embodiments or arrangements of a silicone adhesivelayer suitable for dressing embodiments disclosed herein can beapproximately 380 gm⁻²/24 hrs. Some of the dressing embodimentsdisclosed herein can have a Wacker silres PSA 45 pressure sensitiveadhesive coated thereon.

Additionally, any of the dressing embodiments disclosed herein can havean anti-microbial agent or substance incorporated into the dressing orcoated on one or more surfaces of the dressing. For example, withoutlimitation, the dressing can contain anti-microbial e.g. nanocrystallinesilver agents on the wound contact layer, or otherwise, and/or silversulphur diazine in the absorbent layer, or otherwise. These respectivelycan eliminate micro-organisms in the wound and micro-organisms in theabsorption matrix. A wound contact layer of any dressing embodimentsdisclosed herein can have nanocrystalline silver agents, silver salts,copper salts, or gold salts such as, without limitation, those disclosedin U.S. patent application Ser. No. 11/922,894 (titled ANTIMICROBIALBIGUANIDE METAL COMPLEXES), filed May 21, 2008, which application isincorporated by reference herein as if made part of this disclosure,PHMB, chlorohexadine, peroxide, hypochloride, or other bleaches thereinor thereon.

One or more of such agents can be used separately or together. These canreduce or eliminate micro-organisms in the wound and micro-organisms inthe absorption matrix. As a still further option other activecomponents, for example, pain suppressants, such as ibuprofen, can beincluded. Also agents which enhance cell activity, such as growthfactors or that inhibit enzymes, such as matrix metalloproteinaseinhibitors, such as tissue inhibitors of metalloproteinase (TIMPS) orzinc chelators could be utilized. As a still further option odortrapping elements such as activated carbon, cyclodextrine, zeolite orthe like can be included in the absorbent layer or as a still furtherlayer above the filter layer.

Additionally, adhesive fixation strips can be positioned around theperipheral edges of the any of the dressing embodiments disclosed hereinto provide additional support to the dressing. Such fixation strips canbe advantageous in some situations so as to provide additional sealingagainst the skin of the patient surrounding the wound site. For example,the sealing or fixation strips can provide additional sealing for when apatient is more mobile. In some cases, the fixation strips can be usedprior to activation of the pump assembly, particularly if the dressingis placed over a difficult to reach or contoured area. In anyembodiments disclosed herein, the dressing kit can be provided with upto five sealing strips.

Moreover, some embodiments disclosed herein are directed to systems thatinclude negative pressure therapy apparatuses and dressings, and methodsand algorithms for operating such negative pressure therapy apparatusesfor use with negative pressure therapy dressings. In some embodiments, anegative pressure therapy apparatus comprises a pump assembly configuredto, inter alia, provide negative pressure to a wound. Some embodimentsof pump assemblies disclosed herein comprise novel and inventive controllogic configured to control the operation of the pump assembly. Forexample, some embodiments comprise novel and inventive control logicconfigured to control the operation of a pump assembly in response tomonitoring and detecting various operating conditions, such as presenceand/or severity of a leak or leaks in the system, rate of flow of fluid(e.g., air, liquid and/or solid exudate, etc.) aspirated from a wound,and the like. In some embodiments, the control logic can be configuredto detect a leak or leaks in a system (e.g., leak or leaks in thedressing that is in fluid communication with the pump, leak or leaks inthe seal created by the dressing over the wound, etc.) as well as tocontrol the operation of the pump assembly when such leak or leaks aredetected. In some embodiments, the pump assembly can be configured todistinguish between at least a normal or low leak (e.g., a leak that hasa relatively low flow rate), a high leak (e.g., a leak that has arelatively high flow rate), and a very high leak (e.g., a leak that hasa relatively very high flow rate). Some embodiments can further beconfigured to also distinguish between the aforementioned leaks and anextremely high leak.

The operation of the pump can be controlled by the use of one or morebuttons, pull tabs, sliding switches, or other similar features.

In some embodiments, the dressing kit can comprise a source of negativepressure, such as a miniature, disposable pump, powered by a powersource. The pump assembly can be configured to provide therapy for apredetermined period of time, such as approximately 1 day, 1 or 2 to 10days, 1 or 2 to 14 days, etc. In some embodiments, the pump assembly canbe required to provide uninterrupted therapy for such period of time. Insome embodiments, the pump assembly can be configured to deactivateitself a predetermined period of time (e.g., 7 days) after an initialactivation. The algorithms or logic disclosed herein can help the pumpassembly operate more efficiently and conserve power, for example butwithout limitation, battery power.

In any embodiments disclosed herein, the pump, circuit board or othercontroller, indicator lights, audible or visual alarms, and/or any otherelectronic components (collectively referred to herein as “pumpelectronics”) of the dressing embodiments disclosed herein can bepowered by one or more batteries (for example, two batteries) and canweigh approximately 84 grams, or less than 90 grams, including theweight of the batteries. In some embodiments, the pump assembly canweigh less than 84 grams, including the weight of the batteries, or canweigh from approximately 80 grams to approximately 90 grams, fromapproximately 75 grams or less to approximately 100 grams, or betweenany values within the foregoing ranges. The weight and/or size of thepump assembly can be reduced by reducing the battery size and/or weightto, for example, AAA sized batteries, or smaller, or to one or more flatlithium batteries, or by using an array of batteries.

For example, in some embodiments, the pump can be powered by a single1200 mAh lithium battery. A non-limiting example of a battery that wouldbe suitable is a JAUCH LiMnO₂ battery having a nominal voltage of 3.0volts, a nominal capacity of 1200 mAh, a maximum continuous dischargecurrent of 150 mA, a max pulse discharge current of 300 mA, a length of40.0 mm, a width of 25.0 mm, a thickness of 5.0 mm, and a weightapproximately 9.5 grams or less. The dimensions and/or weight of thebattery can be reduced if a smaller capacity, voltage, and/or current isdesired. For example, in any of the dressing embodiments disclosedherein, a plurality of lithium batteries can be used, each having areduced size and weight as compared to the single battery describedabove. In any embodiments disclosed herein, any number of batteries(including any of the battery types disclosed herein) and/or capacitorscan be positioned about the dressing cover layer and/or any of thedressing layers beneath the cover layer, the pump housing, and/or theconduit providing reduced pressure from the pump to the dressing, ifsuch conduit is used. In any dressing embodiments, as described herein,the pump can be positioned directly on the dressing an configured suchthat no conduit is needed.

Any embodiments of the pump assembly and dressings disclosed herein canhave a plurality of small capacitors, flexible batteries, and/or printedbatteries supported by the dressing, the pump, and/or the conduitbetween the pump and the dressing, or otherwise. For example, an arrayof flat batteries can be distributed across the dressing cover layer,within the dressing layers under the cover layer (including beingpositioned across a plurality of the dressing layers), and/or across anyconduit positioned on the dressing or between the pump and the dressing.Additionally, the weight and/or size of the pump assembly can be reducedby reducing the pump size and/or weight.

The batteries of any of the embodiments disclosed herein can be lithiumchloride, lithium ion disulfide, lithium manganese dioxide or any othersuitable batteries that are suitable for exposure to ethylene dioxideand/or other sterilization gases. Lithium air or zinc air batteries canalso be used with any embodiment disclosed herein. Coin shaped or buttonshaped batteries of any composition can also be used with any embodimentdisclosed herein. The batteries can be supported outside of the pumphousing so as to minimize or eliminate the chance of an electrical sparkwhich could cause an explosion in the presence of the sterilization gasor an explosive gas during the sterilization process when supported inthe packaging element or elements. Additionally, where there are aplurality of batteries, the batteries can be spaced apart or otherwiseseparated in the packaging to prevent any power loss or sparking of thebatteries during the sterilization process or otherwise before usage.

Additionally, in any embodiments disclosed herein, the power source forthe pump can be provided by one or more flexible batteries. For example,one or more flexible printed batteries based on the technology developedby Imprint Energy and/or Solicore. For example, in any embodimentsdisclosed herein, the power source can comprise one or more lithiumpolymer batteries manufactured by Solicore, Inc. Solicore Flexionlithium polymer batteries are ultra-thin, flexible, and have a highenergy density. For example, in some embodiments, the power source canhave a plurality of thin, flexible lithium polymer batteries. In anyembodiments disclosed herein, the power source can comprise a pluralityof thin, flexible lithium polymer batteries each having a nominalcapacity of approximately 10 to approximately 14 mAh or greater, and avoltage of approximately 3.0 V. In some embodiments, the batteries caneach have a size of approximately 26 mm by approximately 29 mm, orapproximately 49 mm by approximately 23 mm, and a thickness ofapproximately 0.45 mm.

In any embodiments disclosed herein, the power source can have fromapproximately 6 to approximately 10 flexible batteries, or fromapproximately 10 to approximately 50 or more flexible batteries,depending on the spatial area of the battery, having a thickness ofapproximately 0.5 mm or less. In any embodiments disclosed herein, thepower source can have one or more batteries having a thickness ofapproximately 0.5 mm or less, or approximately 0.45 mm or less, and canbe configured to have a total nominal capacity of from approximately1000 mAh or less to approximately 1200 mAh.

Additionally, in any embodiments disclosed herein, the power can beprovided by one or more carbon zinc flexible batteries manufactured byBlue Spark Technologies, built on 1.5V carbon-zinc battery chemistry.Voltages above 1.5V can be provided to the pump embodiments by providingmultiple battery cells in series. Providing one or more flexiblebatteries in parallel can increase the total capacity of the powerprovided by the plurality of batteries. The Blue Spark Technologies STseries printed batteries can provide peak drain currents ofapproximately at least 1 mA. Such batteries can have a thickness of lessthan 500 micron (0.020 in). For example, the Blue Spark Technologies110-ST1 battery provides 1.5V, has a capacity of 30 mAh, a peak draincurrent of 1-2 mA, a height of 55 mm (2.17 in), a length of 47 mm (1.87in), and a thickness of 750 microns (0.029 in). The Blue SparkTechnologies 111-ST1 battery provides 1.5V, has a capacity of 54 mAh, apeak drain current of 1-2 mA, a height of 78.7 mm (3.10 in), a length of47.6 mm (1.87 in), and a thickness of 750 microns (0.029 in). The BlueSpark Technologies 111-ST1 battery provides 1.5V, has a capacity of 37mAh, a peak drain current of 1-2 mA, a height of 79 mm (3.10 in), alength of 47 mm (1.87 in), and a thickness of 500 microns (0.020 in).

Any of the foregoing printed batteries, or similar printed batteries,can be used to provide a power source to any of the pump electronics ofany of the dressing embodiments disclosed herein. Additionally, any ofthe batteries, including the flexible batteries, disclosed herein can beformed in a flat, planar relaxed shape, curved relaxed shape, or anyother desired shape. Though not required, in any embodiments disclosedherein, the power source (including the thin, flexible batteries) can bepositioned or distributed over or within the dressing absorption,transmission, and/or backing layers, positioned about the housing forthe pump assembly, and/or positioned about the one or more layerscomprising the conduit (if any) between the pump assembly and thedressing absorption, transmission, and/or backing layers.

Further, as in any of the dressing kit embodiments disclosed herein, thedressing kits can be configured such that the conductive connectionsbetween the power source and the pump assembly can be separated by apull tab, isolation tab, activation switch, or other isolation mechanismto prevent any power supply from being provided to the pump assemblyduring sterilization, shipment, or handling prior to initiation of thenegative pressure therapy.

In some embodiments, the pump assembly can be configured such that thebattery connections or terminals have polarity protection. For exampleand without limitation, one or more of the battery contacts can beconfigured to have plastic or other non-conductive protrusions adjacentto the battery terminal contacts to inhibit the contact between thebattery contact and the incorrect side of a battery that is insertedinto the battery compartment in the incorrect orientation. In someembodiments, the one or more protrusions can be sized and configured toprevent the negative side of a standard cylindrical battery fromcontacting the battery contact adjacent to the one or more protrusions,while permitting a positive side of such battery to contact the batterycontact. Generally, with this configuration, the battery can generallyonly make contact with the contact if the battery is inserted in thebattery compartment in the correct orientation, thereby providingpolarity protection to the pump assembly. Alternatively or additionally,a control board of the pump assembly can be configured to have polarityprotective features or components. Additionally, a control board of thepump assembly can have one or more fuses to protect against overpowerconditions or surge power conditions.

Additionally, any of the dressing embodiments disclosed herein can haveone or more photovoltaic cells configured to provide energy to the pumpelectronics. Though not required, the embodiments having one or morephotovoltaic cells can additionally have one or more batteries orcapacitors configured to provide energy to the pump electronics. Thephotovoltaic cells, batteries, capacitors, and/or other suitable powersources of any of the dressing kit embodiments disclosed herein can bepositioned about at least one of the dressing cover layer, the pumphousing, and the conduit between the pump housing and the dressing coverlayer.

In any embodiments disclosed herein, the conduit can have a plurality ofarticulations in along the length thereof, configured to bias theconduit to a shorter length state. The conduit can be extended ifincreased length is needed. Additionally, in some embodiments, aconnector (or first connector) can be positioned at an end portion ofthe conduit to connect the conduit to a mating connector (or secondconnector) on the dressing. In some embodiments, the connector can beconfigured to activate the pump once the connector is attached to amating connector fixed to the dressing.

For example and without limitation, in some embodiments, the dressingkit can have a pair of wires or electrical conductors extending from thepump assembly to the first connector. The two conductive wires orelectrical conductors can form an open circuit along the length of theconduit. A low voltage can be provided through one of the two conductivewires, sufficient to activate the pump when the two conductive wires arein communication with one another. The two electrical conductors canterminate in a first set of electrical contact points. A secondconnector supported by the dressing can be configured to engage thefirst connector and can have a second set of electrical contact points.The second contact points can be electrically connected such that, whenthe first connector is fully engaged with the second connector supportedby the dressing, the first set of contact points will be in contact withthe second set of contact points, and close the circuit between the twoconductive wires in the conduit to activate the pump.

Some embodiments of the pump assembly can be configured to abate noiseand/or vibration of the pump during operation. Noise canceling chips canbe used in some embodiments to reduce noise. In some embodiments, thepump output can be configured to ramp in and ramp out or graduallyincrease and decrease to eliminate sudden changes in the operation ofthe pump, thereby minimizing or eliminating any sudden transitions.Additionally, in any of the embodiments disclosed herein, the pumpassembly or pump motor can be supported within a silicone or foamenvelop or layer to attenuate vibration and noise.

Additionally, in any of the embodiments disclosed herein, the pumpassembly or dressing member can be configured to support an organiclight emitting diode (“OLED”) display or other suitable interfacedisplay.

Some of the embodiments comprise a pump and/or a pump and dressing kit.Some embodiments are directed to a pump and/or pump and dressing kitthat have been sterilized before delivery to the hospital, operatingroom or theatre, or to the medical practitioner using such devices suchthat the sterile pump and/or a sterile pump/dressing kit can be appliedimmediately following the surgical or operating procedures. Oneadvantage of this is that the surgeon can release the patient from theoperating room knowing that the reduced pressure pump is operating andthat the reduced pressure therapy has been started at the earliest pointin time possible. A further advantage of applying the dressing kitimmediately following the surgical or other procedure is that doing socan reduce the chance of infection by eliminating a subsequent dressingchange that may otherwise be required in the ward. In other words, forthose patients where a dressing (but not a pump) is applied in theoperating theatre and then a problem is found thereafter, such as a leakor other issue with the dressing, if the dressing is required to beremoved to be repositioned, replaced, or otherwise after the patient isreleased from the operating theater, the patient's wound can be exposedto infection risk when the dressing is repositioned, replaced, orotherwise outside of the operating theater. However, with theembodiments disclosed herein, if the pump is applied and tested whilethe patient is in the operating theater, any issues with the dressingthat may require the dressing to be removed, repositioned, or otherwise,can be handled in the sterile operating room environment, therebysignificantly reducing or eliminating the risk of exposure to pathogens,bacteria, or other contaminants. Further, it is generally not possiblefor a hospital to sterilize a traditional pump once it has been receivedby the hospital, and therefore the hospital may resort to bagging thepumps in sterile bags but risk compromising the operating room sterilefield with this approach, particularly once the device is turned on andpathogens, bacteria, or other contaminants that may be inside the pumpare release due to the operation of the pump.

In some embodiments, the pump can be configured to be amenable to gassterilization, having features, components, and other characteristicsthat make the pump amenable to full sterilization gas exposure andpenetration throughout the components of the pump. For example, withoutlimitation, one or more pump valves have been selected or configured topermit a sufficient flow of sterilization gas therethrough such that theentire fluid pathway within the pump can be exposed to the sterilizationgas. As will be explained in greater detail below, in some embodiments,the pump can have other components, such as without limitation,strategically positioned one way flow valves, to complement the othervalves within the pump, which can improve the efficiency of the pump byreducing leakage through the flow pathway within the pump assembly.

Additionally, where provided, the sterile pump/dressing kit can also bedesigned and configured to be amenable to gas sterilization. Asdescribed below, the sterile pump/dressing kit can be configured suchthat all of the components comprising the sterile pump/dressing kit,including the pump assembly, are packaged together in at least a firstpackaging element before sterilization, permitting all of the componentsto be sterilized together. Furthermore, as will be described, thecomponents comprising the sterile pump/dressing kit can be arranged inthe packaging such that at least some of the components can be removedin a predefined order, making it easier for the surgeon or medicalpractitioner to assemble and apply the dressing to the patient.

There are a number of benefits to being able to begin treatment of awound in the operating theater, including without limitation providing asubstantially sealed barrier over the wound while the wound is in asterile condition and environment that will inhibit or prevent bacteriaor other contaminants from getting into the wound. Additionally,initiating the reduced pressure treatment at the earliest stage possibleis also advantageous to healing of the wound.

The housing of any of the pump assembly embodiments can be configuredsuch that a sterilization gas, such as ethylene dioxide, can penetrateinto the housing such that the internal components of the pump assemblyare exposed to the sterilization gas during normal sterilizationprocesses. Typically, the pump will be exposed to the sterilization gasin a chamber that has been substantially evacuated of air or any othergas, so that the sterilization gas is drawn into the pump housing andinto the other spaces and chambers within the pump assembly. Forexample, some embodiments of the pump housing can have an unsealed gapsurrounding the connector through which the sterilization gas can pass.Also, in some embodiments, the first housing member can be joined to thesecond housing member without the use of a seal therebetween, and thepump assembly can have one or more valves that permit a sufficientamount of sterilization gas therein to effectively sterilize all of theinternal components of the pump.

In some embodiments, the pump assembly can be mounted to any of thedressing embodiments disclosed herein and can have any suitable pumpcomponents (including, without limitation, a standard off-the-shelfvacuum pump such as the Koge Electronics KPV8A-3A pump). Someembodiments of the pump can be approximately 37 mm (length)×20 mm(width)×8 mm (depth). In any of the embodiments disclosed herein, one ormore of the pumps can be a piezoelectric pump or a diaphragm pump or anyother suitable pump. Additionally, in some embodiments, the pump can bea voice coil actuated pump.

The batteries can be lithium or zinc air activatable batteries, thoughnot so required. If the dressing kit is to be sterilized, the batteriescan be separated during the sterilization process by positioning anon-conductive barrier between the batteries. Additionally, toaccommodate current legislation regarding battery disposal, someembodiments of the pump assembly can be configured such that thebatteries are easily removable or separable from the dressing, forexample before the dressing is removed from the body, for disposal afterthe dressing kit and pump assembly have been used.

In some embodiments, the pump can be configured such that the pump needsto be powered on at the start of the treatment cycle. Additionally, thepump can be configured such that the pump needs to be re-started when aleak is detected and dressing has been assessed. Regarding leaks, thepump assembly and dressing kit can be configured such that the deviceprovides the following operation indications, without limitation:communication of device operating correctly; communication of leak beingfound; communication indicating that the dressing is full; and/orcommunication of a low or dead battery. The pump can be configured tocommunicate in multiple different languages. Any embodiments of the pumpdisclosed herein can be configured to communicate in 19 or moredifferent languages. Any embodiments of the pump disclosed herein can beconfigured to maintain reduced pressure in the wound site betweenapproximately 60 and approximately 80 mmHg, or between approximately 60and approximately 130 mmHg.

FIGS. 1-5 illustrate five dressing embodiments, the dressing beingconfigured to support the pump and power source such that the pump andpower source is on-board the dressing. In any of the embodiments herein,the power source used to provide power to the pump electronics can haveone or more batteries, one or more capacitors, one or more photovoltaiccells, one or more fuel cells, or any combination of the foregoing. Suchpower sources are collectively referred to herein as “power source.”

Any of the embodiments illustrated in FIGS. 1-5 or elsewhere in thisdisclosure can comprise any feature, component, material, and/or detailsof any or all of the other embodiments described herein. FIGS. 1A-Billustrate one embodiment of a dressing kit 50 having a pump assembly 52supported by the dressing 54 at a corner 54 a of a dressing 54. Thepower source 52 of this embodiment or any dressing kit embodimentdisclosed herein can have any of the types of batteries disclosed hereinor otherwise, including printed and/or flexible batteries, lithiumbatteries, and/or air activatable batteries 56, or can have one or morecapacitors, photovoltaic cells, fuel cells, or otherwise. Having thepump assembly 52 on the corner 54 a of the dressing 54 can improve thehandleability of the dressing 50.

In some embodiments, the power source 52 can be positioned along theshort edge of the dressing 54 and the pump assembly 52 can be positionedalong the long edge of the dressing 54, or vice versa. In any of thedressing embodiments disclosed herein, a control board and/or userinterface, which can include operation buttons, visual displays, alarms,indicator lights, or otherwise, can be positioned in any desiredposition on the dressing, including above or below the backing layer(the backing layer being the outermost dressing layer), integratedwithin the dressing layers positioned beneath the backing layer, orotherwise.

As further illustrated by FIG. 1A, some embodiments of the invention caninclude a removable label 58. The removable label 58 can be made of anairtight polymer material or any other suitable material. The removablelabel can be removably fixed to the batteries 56 via an adhesive or anyother suitable mechanism. Removing the label 58 can expose the batteries56 to air, thereby activating the batteries 56.

FIG. 1B illustrates the dressing 50 with the label 58 removed. When thedressing 50 is applied to a wound, the corner placement of the pumpassembly 52 and batteries 56 can frame the wound. For example, the pumpassembly 52 and the batteries 56 can lay outside the periphery of thewound and attach to healthy skin. Further, the pump assembly 52 andbatteries 56 can be raised from the surface of the skin, such that ifthe patient bumps into an object, the raised surface prevents damage tothe wound.

Though not required, in some embodiments, the pump assembly can bepositioned on one end of the dressing and the batteries or other powersource can be positioned on another side or end of the dressing, such asthe opposite side. This arrangement can result in a more balanceddressing in terms of weight, rigidity, and/or size.

In some embodiments, as with the dressing kit 70 embodiment illustratedin FIG. 2B, the pump 72 and power source 76 can be positioned atopposite ends of the dressing 74. With reference to FIG. 2, the pumpassembly 72, printed circuit board (PCB) or other pump controller, andbattery assembly 76 can be positioned in recesses or openings formed inthe dressing material or foam 78, or can be embedded within the foam ordressing material 78. The foam or dressing material 78, with the pump 72and/or power source therein, can be flexible and conformable to curvedor contoured body surfaces. An elastomeric carriage 84 can line thedressing material or foam 78 close to the pump 72, PCB, and battery 76.The elastomeric carriage 84 can provide flexibility to the dressing 70.The pump assembly 72, PCB, and battery assembly 76 can be configuredsuch that the components are flexible to permit the wound dressing 70 tobend about the body or flex with the movement of the body. For example,a hinge can be provided between the pump assembly 72, PCB, and/or thebattery 76 to permit flexibility. Additionally, the portion of thedressing 74 supporting the pump 72 and/or battery 76 can be configuredto provide a handle, to improve the handleability of the dressing duringplacement of the dressing on the body. Separating the battery 76 on thedressing 70 also has the benefit of permitting the battery or batteries76 to be easily removed after use for separate disposal.

In any of the dressing kit embodiments disclosed herein (which includesthe pump embodiments supported remote to the dressing, such as adjacentto the dressing), the PCB or pump controller can be a flexible circuitboard and/or can have one or more flexible components. A flexiblecircuit board is generally a patterned arrangement of printed circuitryand components that utilizes flexible based material with or withoutflexible overlay. These flexible electronic assemblies can be fabricatedusing the same components used for rigid printed circuit boards, butallowing the board to conform to a desired shape (flex) during itsapplication. In their simplest form, flexible circuits are PCBs made ofmaterials that allow for a non-planar positioning within the endproduct. Typical materials a polyimide-based, and can go under tradenames such as Kapton (DuPont). Additionally, any of the control boardsor controllers disclosed herein can have a combination of flexible andrigid substrates laminated into a single package.

Additionally, in any embodiments, the circuit boards can be printed onany desired substrate, including printing the circuits on one or moresurfaces of the pump housing, on one or more dressing layers orsurfaces, on one or more conduit and/or port layers or surfaces, or anycombination of the foregoing.

In any of the dressing embodiments disclosed herein, with reference toFIG. 2A, malleable metal or other materials (such as metal wires orstrips) 84 can be added to the dressing 70 to maintain the shape of thedressing 70 after it has been molded to the body surface. The malleablematerial 84 can be under, within, or above the gauze. Additionally, themalleable material 84 can be positioned under, within, or above thecover layer. The malleable material 84 can be positioned in a parallelarrangement, as illustrated by FIG. 2, or in any other suitablearrangement.

Additionally, in any embodiments disclosed herein, a hinge (such as aliving hinge) can be positioned between the various componentscomprising the pump assembly, such as between a control board and thepump motor 72, or between an power source 76 and the pump 72, to improvethe flexibility of the pump assembly and/or dressing kit. Printedconnectors could be used to provide electrical connections between thePCB and the pump motor 72 and/or between the batteries 76 and the PCB orpump motor 72. Additionally, in any embodiments disclosed herein, ifboth the pump assembly 72 and the batteries 80 are positioned at one endof the dressing 70, a foam handle could be positioned at the other endto improve the handleability of the dressing 70.

As illustrated in FIG. 3, the dressing kit 90 can be configured suchthat both the pump assembly 92 and the power source 94 can be positionedon one end 96 a of the dressing 96. As shown in FIG. 3B, a cover 98 canbe positioned over the pump 92 and power source 94 to contain thosecomponents. The cover 98 can be supported by the dressing 92 with aliving hinge 100 or by any other suitable mechanism. The dressingcontact layer 102, the packing layer 104, and the cover 106 can haverounded corners. The dressing can come in a variety of lengths andsizes, as illustrated by FIG. 3C. Additionally, a pull tab, as furtherdescribed herein, can be used for activation and deactivation of thepump. Additionally, in this and any other dressing embodiments disclosedherein, the border around the dressing can be baggy or have additionalslack or material therein to for increased user movement.

With reference to FIG. 4, in some embodiments of the dressing 110, thepower source 112 (which can comprise one or more batteries) and pumpassembly 114 can be positioned along the lengthwise side 116 a of thedressing 116. Referring to FIGS. 4A-C, the dimensions of the dressing110 according to some embodiments of the invention can be approximately50 mm×100 mm, 100 mm×150 mm, or 100 mm×250 mm, respectively. In theseembodiments, the power source 112 and pump assembly 114 can be placedalong the side of the dressing measuring 100 mm, 150 mm, and 250 mm,respectively. Although FIG. 4A illustrates various dimensions of thedressing 116, it will be appreciated that the dimensions can be of anysuitable length and width.

The power source 112 (which can have one or more batteries) and pumpassembly 114 can be separated, as shown in FIG. 4C, or can be positionedadjacent to one another, as illustrated in FIGS. 4A and 4B. Thisarrangement can result in the pump assembly 114 being more flush to theuser's body, to prevent or reduce the risk of dislodgement anddiscomfort. Additionally, positioning the pump 114 at one end and thebatteries 112 at the other end can result in greater conformability ofthe dressing kit 110 to the body, and increased comfort and performanceof the dressing kit 110. Referring to FIG. 4C, separating the powersource 112 and the pump assembly 114 can increase the flexibility of thedressing 110. Both enhance flexibility and enhanced conformability canimprove the dressing's seal to the body, to reduce leakage pathways tothe space between the dressing and the wound.

With reference to FIGS. 5A-B, any embodiments disclosed herein of thedressing kit 130 can have one or more zinc air activated batteries 136that can activate the pump 132 with air that is introduced to thebatteries 136. The batteries 136 and pump assembly 132 can be positionedalong an end portion 138 a of the dressing 138. The batteries 136 can below profile to reduce the profile of the dressing 130. As illustrated byFIGS. 5A-B, the batteries 136 and pump assembly 132 can be placed on anend portion 138 of the dressing 130 according to some embodiments of theinvention. The batteries 136 and pump assembly 132 can be placed alongthe shorter side (as illustrated in FIG. 5A) or the longer side (asillustrated in FIG. 5B) of the dressing 138. Therefore, in anyembodiments disclosed herein, the pump and power source can bepositioned adjacent to one or more packing layers of the dressing, andcan be positioned adjacent to an edge of a cover layer to reduce thelikelihood that the power source and/or pump will be positioned over thewound.

As shown in FIG. 6A, in any embodiments disclosed herein, the dressingfilm or cover layer 152 can extend beyond the dressing borders and forma loop 154 at one end to improve the handleability of the dressing 150and prevent the dressing from flopping around or becoming limp andunhandleable during application of the dressing to the body. The loopedover support layer could be removable, to permit the support layer to beremoved after positioning the dressing on the body. Additionally, insome embodiments, the pump 156 and/or battery source 158 can bepositioned in a corner of the dressing 152 or in any other suitablelocation. In this or any other embodiment disclosed herein, the dressing152 and/or pump assembly 156 can have one or more press studs to providemechanical attachment between the dressing and the pump assembly, and/orto loop and removably hold the dressing layer in the desired loopedconfiguration.

With reference to FIG. 7, the dressing kit 170 can be arranged such thatthe pump assembly 172 can be supported by the dressing 174 in an offsetposition so that the pump assembly 172 is not positioned over anyportion of the dressing 174. A conduit can be used to communicate thereduced pressure produced by the pump assembly 172 to the dressing 174and wound. The dressing kit 170 can be configured such that the pumpportion 172 can be easily removed for disposal of the pump assemblyseparate from the dressing. In any embodiments disclosed herein, thedressing can have a one or more cuts, channels, scores, reducedthickness portions, partial thickness cuts, or perforations 178 betweena first portion 174 a of the dressing 174 supporting the pump assemblyand a second portion 174 b of the dressing 174 having one or moreabsorbing layers 180 to be positioned over the wound.

As such, any dressing member disclosed herein can be configured to haveat least a first portion and a second portion configured to be separablefrom the first portion by hand and without the use of tools. Thedressing member can be configured to be torn by hand to separate thefirst portion from the second portion. Additionally, positioning thepump 172 and power source (e.g., batteries) adjacent to the wound siteinstead of over the wound site can improve the comfort to the user bypreventing the pump assembly and/or power source from contacting thesensitive wound bed. The dressing 174 can have at least one continuouslayer that covers the entire dressing 174. The dressing member 174 canbe approximately air-tight adjacent to the perforations or boundarybetween the first and second portions so that, upon separation of thesecond portion from the first portion of the dressing, no air leaksresult.

FIG. 8 is an illustration of another embodiment of a dressing kit 190having a dressing 192, a pump 194, and an power source 196. Asillustrated in FIG. 8, the pump assembly 194 can be positioned over orwithin the wound packing material 196 over the wound, while the powersource 196, which can have one or more batteries, can be positioned inan offset position on the dressing. For example, in some embodiments,the power source 196 can be positioned on a first portion 192 a of thedressing 192, which the pump assembly 194 can be positioned on a secondportion 192 b of the dressing 192. The absorbing or packing layers 196can be positioned on the second portion 192 b of the dressing 192.

In some embodiments, one or more cutouts 198 can be formed in thedressing between the first portion 192 a and the second portion 192 b toimprove the flexibility of the dressing and to permit betterarticulation of the dressing. In this configuration, the dressing canhave a narrowed or necked portion between the first and second portions.In some embodiments, a perforation 200 can be formed in the dressing 192to permit separation of the first portion from the second portion of thedressing 192. This can facilitate the separation of the power source 196from the rest of the dressing upon termination of the treatment fordisposal of the two portions.

FIG. 9 illustrates an additional embodiment of a dressing kit 210,having a dressing 212, a pump assembly 214, and an power source 216. Aswith any of the embodiments disclosed herein, the power source 216 canhave one or more flexible or rigid batteries of any of theconfigurations disclosed herein. In any embodiments disclosed herein, asillustrated in FIG. 9, the power source 216 can be freely positionablerelative to the dressing 212, either on or adjacent to the dressing 212.A printed ribbon or wiring 218 can provide an electrical connectionbetween the power source 216 and the pump assembly 214. This arrangementcan improve the ability of the user or medical practitioner to changethe batteries during operation of the dressing kit, can improve theflexibility of the dressing 212, and can move heavy and/or semi-rigidobjects away from the wound surface. Additionally, detaching andreattaching the batteries can be used for deactivating and activatingthe pump.

FIG. 10 illustrates an embodiment of a dressing kit 230 wherein the pumpassembly 232 and batteries 234 are positioned adjacent to the dressingpacking or absorption layers 236 of the dressing 238. In someembodiments, the dressing member 240 and the transmission layer 242 canterminate adjacent to the pump assembly 232 and the batteries 234 suchthat the pump 232 and batteries 234 can be positioned on an outsidesurface of the backing layer 240, with no dressing absorbing layers 240or transmission layer 242 beneath the pump 232. Only the backing layer244 and the wound contact layer 246 are positioned under the pumpassembly 232 and batteries 234.

Alternatively, with reference to FIG. 11, in some embodiments, anadditional layer (which can be a transmission layer, spacer layer,absorption layer, and/or a 3D knitted or 3D fabric layer) can bepositioned under the pump 232, between the backing layer and the woundcontact layer 246. For example, in any embodiments, the pump can bepositioned over a 3D knitted and/or fabric layer (such as the 3D knittedand/or fabric layer 237 shown in FIG. 11) of any of the compositionsdisclosed herein, either with or without a liquid filter beingpositioned between the pump and the 3D knitted and/or fabric layer. Aport in the pump 232 can be in fluid communication with the 3D knittedand/or fabric layer. In any embodiments, the backing layer 244 can bepositioned over the pump 232, with an exhaust valve and/or filter toprevent pathogens, bacteria, odors, or other contaminants from leavingthe pump. Positioning the pump over the transmission of 3D knittedand/or fabric layer can reduce the risk of maceration of the skinbeneath the pump assembly and batteries that can result from the buildupof moisture against the skin, and can improve the comfort of thedressing by providing additional cushion between the pump assembly 232and/or batteries 234 and the skin. This arrangement can also reduce theprofile height of the dressing kit.

In the embodiment illustrated in FIG. 11, or in any other embodimentsdisclosed herein, the dressing kit 230 can have one or more filters orvalves upstream of the pump assembly 232 configured to prevent liquidsand solids from entering the pump 232, but permitting the flow of air orgas through the filter or valve. In the case of a filter, the filter canbe a hydrophobic filter, a hydrophilic filter, an occlusive filter, forexample a membrane having a hydrogel and/or superabsorber material, orany other suitable type of filter or valve configured to prevent thepassage of liquids or solids therethrough. In some embodiments, thefilter or valve can be positioned adjacent to a port member, beneath thepump assembly, or otherwise positioned upstream of the pump assembly.For example, for the embodiment illustrated in FIG. 11, the filter canbe positioned between the pump assembly 232 and the backing layer 244,between the backing layer 244 and the wound packing layer 246 beneath oradjacent to the pump assembly 232, or in any other suitable location. Inthe embodiment illustrated in FIG. 11, the backing layer 244 can have apuncture, opening, or other port feature adjacent to the filter toprovide the passage of air through the backing layer 244 to the pumpassembly 232.

Additionally, in some embodiments, the pump can be directly positionedon top of the wound contact layer, but have a port in communication withthe 3D knitted and/or fabric layer so as to provide a source of negativepressure directly to the 3D knitted and/or fabric layer. As mentionedabove, a liquid filter or liquid barrier can be positioned between thepump 232 and the 3D knitted and/or fabric layer to prevent liquid fromentering the pump. In any of these embodiments, an absorption layer(which can be a superabsorbing layer) can be positioned above the 3Dknitted and/or fabric layer or other transmission layer and can beconfigured to wick fluid out of the 3D knitted and/or fabric layer orother transmission layer.

The pump assembly 232 and/or batteries 234 can be positioned at an edgeportion of the dressing 238, as illustrated in FIG. 11, or can bepositioned inside of an edge portion of the dressing, as illustrated inFIG. 12. A double layer of absorptive material 238 can surround the pumpassembly 232. Some embodiments only have a single layer of absorptivematerial 238. Additionally, with reference to FIG. 13, in any dressingkit embodiment disclosed herein, the pump assembly 232 and/or batteries234 can be positioned inside an edge portion of the dressing 238 andbeneath the backing layer of the dressing in a depression or cutout thatpasses through the entire thickness of the absorptive layers so as to bepositioned on top of the transmission layer 237. A port from the pumpcan be in communication with the transmission layer 237 so as to providenegative pressure to the transmission layer 237. A liquid filter toprevent liquid from passing through the pump can be positioned betweenthe pump and the 3D knitted and/or fabric layer or other transmissionlayer, such as the 3D knitted and/or fabric layer 237 shown in FIG. 12.

Additionally, in any embodiments, the pump can be positioned in adepression formed in the absorption layer so as to be positioneddirectly on top of the transmission layer. A port in the pump can bepositioned so as to be in communication with the absorption layer sothat negative pressure is applied directly to the absorption layer. Someembodiments can have a perforated or permeable polymeric film betweenthe absorption layer and the transmission layer, such as a polyurethaneor polyethylene layer.

Further, in any embodiments disclosed herein, the pump can be positioneddirectly over the transmission layer (which can be a 3D knitted and/orfabric layer, or any other suitable transmissive material), eitherembedded within one or more absorption layers or positioned adjacent toone or more absorption layers. In such arrangements, an impermeable filmcan be positioned between the transmission layer and the absorptionlayer, surrounding the pump. The pump can be configured to applynegative pressure directly to the transmission layer and to draw liquidfrom the transmission layer through the pump and exhaust such liquidinto the absorption layer. An impermeable backing layer can be, but isnot required to be, positioned over the pump assembly. In anyarrangements wherein the pump is located under the backing layer, afiltered or unfiltered exhaust port can be formed in the backing layerto ensure that gas can be exhausted from the dressing. In someembodiments, a bacteria, pathogen, or other contaminant filter can bepositioned within the pump assembly.

In any dressing kit embodiments disclosed herein, the 3D knitted and/orfabric layer can have any of the properties of any of the dressinglayers disclosed in U.S. Patent Application Publication No. 2011/0282309(Ser. No. 13/092,042), (titled WOUND DRESSING AND METHOD OF USE), filedApr. 21, 2011, and/or PCT Patent Application Publication No. WO2011/087871 (International Patent Application No. PCT/US2010/061938),(titled APPARATUS AND METHODS FOR NEGATIVE PRESSURE WOUND THERAPY),filed internationally on Dec. 22, 2010, which applications are herebyincorporated by reference as if fully set forth herein.

The power source for any of these embodiments can be positioned withinthe pump assembly housing, can be positioned adjacent to the pumpassembly housing and supported by the dressing, either within or abovethe absorptive layers adjacent to or apart from the absorptive layers,can be positioned on top of the absorptive layers, or can be positionedin a remote position apart from the pump assembly. With reference toFIG. 13, in any embodiments, the pump assembly 232 and/or batteries 234can be positioned inside an edge portion of the dressing 238 and beneaththe backing layer of the dressing in a depression or cutout that passesthrough the entire thickness of the absorptive or transmission layers soas to be positioned on top of the wound contact layer 246.

Further, any of the dressing kit embodiments disclosed herein can havean exhaust filter downstream of the pump assembly. The exhaust filtercan be configured to prevent the spread of any bacteria, pathogens, orother harmful constituents from leaving the dressing through the exhaustport in the dressing kit. The exhaust filter can be supported by thepump assembly, or supported by any other layer or component of thedressing kit. For example, with reference the embodiment illustrated inFIG. 12 or in any other embodiment wherein the pump assembly ispositioned beneath the backing layer, the exhaust filter can besupported by the backing layer or within or adjacent to an opening orport in or on the backing layer.

In any of the embodiments disclosed herein, including without limitationthe embodiments illustrated in FIGS. 12 and 13, the pump assembly 232and/or batteries 234 can be positioned under the backing layer 244.Additionally, in some embodiments, the pump assembly 232 and/orbatteries 234 can be embedded within one or more of the absorptionlayers 236 of the dressing 238. This configuration can reduce theprofile of the dressing kit 230, improve the ability of the pumpassembly and/or batteries to withstand impact, and provide a moreaesthetic design. In some embodiments, the backing layer 244 can beperforated or gas permeable to permit gas exhausted by the pump assemblyto pass through the backing layer 244. Additionally, in any of theembodiments disclosed herein, the backing layer 244 can be water vaporpermeable to permit vapor from the liquid within the dressing to passthrough the cover layer 244.

FIG. 14A illustrates another embodiment of a dressing kit 250 having adressing 252, a pump 254, and a power source 256. In some embodiments,as with any of the embodiments of the dressing kits disclosed herein,the pump 254 and or power source 256 can be positioned above, within,partially within, adjacent, or remote to the absorptive and transmissionlayers 258 of the dressing 252. Additionally, in any of the embodimentsdisclosed herein, as illustrated in FIG. 14A, a hinge 262 such as aliving hinge can be positioned between the pump assembly 254 and thepower source 256, which can have one or more batteries. The hinge 262can improve the flexibility and conformability of the dressing 250between the pump assembly 254 and the power source 256. In anyembodiments disclosed herein, the pump assembly 254 and/or the powersource 256 can be configured to be positioned in a casing that does nothave a bottom surface, such that the batteries and/or pump assembly aremore compact. For example, the pump assembly 254 and/or the power source256 can be positioned above one or more of the transmission and/orabsorptive layers 258 of the dressing 252 or a backing layer 264 of thedressing 252 without having any additional layers or materials beneaththe pump assembly 254 and/or the power source 256.

For example, with reference to FIG. 15, the power source 256 (which, inthis illustration, consists of two batteries) is positioned directly ontop of the backing layer 264 so as to minimize the profile of thedressing kit 250 in the region of the power source 256. Additionally, asillustrated, any embodiments disclosed herein can have a molding 255configured to cover and support the power source 256 and/or the pumpassembly 254.

This arrangement can reduce the profile of the pump assembly and/or theone or more batteries and improve the flexibility of the pump assemblyand the one or more batteries. This can be produced in a single moldingwith internal components held captive between the one or more dressinglayers and the upper casing of the pump assembly and/or the one or morebatteries or between very thin layers within the pump assembly and theone or more batteries. The dressing kit illustrated in FIG. 14 can haveany suitable pump type, including without limitation a diaphragm pump, avoice coil pump, a crank pump, or any other suitable pump.

Additionally, in some embodiments, as illustrated in FIG. 16, one ormore transitional members 257 can be positioned adjacent to the pumpassembly 254 and/or the power source 256 to provide a smooth transitionto the height or profile of the pump assembly 254 and/or the powersource 256, underneath the component cover 255. The transitional members257 can be formed from foam, silicone or other rubber, or other soft ormalleable materials to provide flexibility and comfort to the dressingand the user. Additionally, though not required, a thin spacer 261 canbe positioned beneath the pump assembly 254 and/or the power source 256.

FIGS. 14B-14D illustrates another embodiment of a dressing kit 270having a wound dressing 272, a pump assembly 274, a power source 276,and a conduit 277 configured to communicate the negative pressureproduced by the pump assembly 274 to the space between the dressing 272in the wound. In some embodiments, the conduit 277 can have a connector278 fixed to a distal end 277 a of the conduit 277 configured to connectwith the pump assembly 274. A complementary coupling or mating featurecan be supported by the pump assembly 274 to receive the connector 278and provide a substantially sealed connection therewith. In somearrangements, the conduit 277 can be supported on the dressing 272 in ahelical or winding arrangement around the absorptive layers 273 of thedressing 272. Additionally, the conduit 277 can be held in place with asupplemental backing layer 284 configured to adhere to the top of theconduit 277 and the dressing 272 and to hold the conduit 277 in thedesired position. The supplemental backing layer 284 can be configuredto permit a medical practitioner or user to remove a desired length ofconduit 277 from the coil conduit so as to position the pump assembly274 at any desired position either on the dressing 272 or remote to thedressing 272. Additionally, in some embodiments, the supplementalbacking layer 284 can have a cut out or opening in the middle thereofover the portion that covers the dressing and/or absorptive layers 273so as to not inhibit vapor transmission from within the dressing.Additionally or alternatively, the supplemental backing layer 284 canhave a plurality of perforations therein configured to permit vaportransmission through the dressing layers.

Alternatively, the conduit 277 can be adhered to the top of the dressing272 around a perimeter of the dressing and/or transmission layers 273using adhesive or any other suitable mechanism that will removablysecure the conduit 277 in the desired location, but permit a medicalpractitioner or user to remove a desired length of conduit 277 from thecoil so as to position the pump assembly 274 at any desired positioneither on the dressing 272 or remote to the dressing 272. In anyembodiments disclosed herein, the pump assembly 274 and power source 276can be supported on a separate support member 280 so that the pumpassembly 274 and the power source 276 can be positioned at any desiredlocation either remotely relative to the dressing 272, adjacent to thedressing 272, or even on board the dressing 272. The support member 280can have adhesive on a bottom surface thereof for each into any desiredsurface, or any other desired fastening mechanism such as hook and loopconnectors, snaps, wires, or otherwise. Additionally, as describedabove, a flexible hinge 282 can be positioned between the pump assembly274 and the power source 276 to increase the flexibility andconformability of the support member 280. Any of the dressing kitembodiments disclosed herein can have a similar arrangement of conduitas disclosed for the dressing kit 270, or any of the other features,details, or configurations disclosed were shown for dressing kitembodiment 270.

FIG. 17 illustrates another embodiment of a dressing kit 290 having adressing 292, a pump assembly 294, and a power source 296 supported bythe dressing 292 in some embodiments, the pump assembly 294 and thepower source 296 can be positioned adjacent to the one or moreabsorptive and/or transmission layers 298 of the dressing kit 290. Asillustrated therein, the pump assembly 294 and the power source 296 canbe supported on portions of the dressing 292 extending in a V-shapedpattern away from the dressing pad 298. In other words, a cut out 293can be formed in the dressing 292 to permit greater flexibility andconformability of the dressing in the region of the pump assembly 294and the power source 296. In some embodiments, the cut out can have aV-shape. In some embodiments, the cut out 293 can have a U-shaped, or asmooth cutout shape.

Additionally or alternatively, any of the embodiments disclosed hereinof the dressing 292 can also have additional cutouts 295 formed in thedressing 292 to the outside of the pump assembly 294 and/or the powersource 296 to also increase the flexibility and conformability of thedressing. As mentioned, this arrangement can improve the conformabilityand flexibility of the dressing and enable the pump assembly 294 and/orthe power source 296 to better mold around a curved body surface.Additionally, in some embodiments, this arrangement can have a pinpointhinge rather than a lengthwise hinge to permit the components to bettermold over curved or complex surface contours. Any of the dressing kitembodiments disclosed herein can have the pump assembly and the powersource arranged on the dressing in this configuration, and can have adressing of this shape.

FIG. 18 illustrates another embodiment of a dressing kit 310 wherein thepump assembly 314 and the power source 316 are supported by the dressing312 and can have a hinge 322 therebetween. In some embodiments, thehinge 322 can be a living hinge. The hinge 322 can improve theflexibility of the dressing and the components supported thereby.Additionally, in some embodiments, the edges of the pump assembly 312and/or the power source can be tapered and can be flexible.

Additionally, in any embodiments disclosed herein, for example, FIG. 19illustrates an embodiment of the dressing kit 330 that can have adressing member 332, a pump assembly 334, a power source 336, and apressure indicator 342 supported by the dressing 332. Additionally, insome embodiments, a flexible hinge 344 can be molded into, formed on, orpositioned on the support layer or support material used to house orsupport the pump assembly 334 and the power source 336, the hinge 344being positioned between the pump assembly 334 and the power source 336.The pressure bubble or pressure indicator can be positioned 342 weresupported by the dressing 332 in any desired location on the dressing332.

Additionally, as with any other embodiments disclosed herein, one ormore press studs 346 can be supported on an outside surface of the coverlayer of the dressing 332, the press studs being configured to receivecomplementary fastening features on the power source 346 and/or the pumpassembly 334. In some embodiments, as is illustrated in FIG. 19, afilter layer can be positioned beneath the pressure indicator 342.

FIG. 20 illustrates another embodiment of a dressing kit having adressing 352, a pump assembly 354, and a power source 356. In someembodiments, the pump assembly 354 and/or the power source 356 can beremovably attached to the dressing member 352 using one or more studconnectors 362 fixed to the dressing member 352. The use of studconnectors 362 (also referred to herein as metal connectors or snapconnectors) to support the battery and/or pump assembly on the dressingcan enable the removability of the pump and/or power source from thedressing for replacement or for disposal. Additionally, the snapconnectors can be used to not only removably support the battery and/orpump assembly on the dressing, but also to provide an electricalconnection between the one or more batteries and the pump assembly.

In some embodiments, a first snap connector 362 a can engage a firstfemale receiver 364 a positioned on a housing for the pump assembly 354.Similarly, a second snap connector 362 a can engage a second femalereceiver 364 a positioned on housing for the power source 356. The firstsnap connector 362 a can be electrically connected or in communicationwith the second snap connector 362 b so that a current supplied from thepower source connected to the second snap connector 362 b can becommunicated to the pump assembly through such electrical connection orwiring between the two snap connectors. Additionally, in any embodimentsdisclosed herein, the pump and battery module could have a hingetherebetween for added conformability and flexibility. A hinge couldalso be used to connect the pump and battery module to the dressing kit.Further, in any embodiments disclosed herein, the battery and the pumpassembly can be separate modules that can be independently removedand/or replaced.

In any of the embodiments disclosed herein, the batteries can bepositioned and supported apart from the dressing. The batteries can besecured to the body or to the dressing using tape, a local pad, snaps, aclip supported by the dressing, Velcro, and/or any other desiredfastening member. The batteries can be inserted and removed tofacilitate activation and deactivation of the pump, and to permitreplacement and/or disposal of the batteries.

Additionally, in any embodiments disclosed herein, one or more pressstuds can be supported by the dressing. The one or more press studs canbe configured to engage complementary connectors supported by the pumpassembly and/or the one or more batteries to permit the pump assemblyand/or the one or more batteries to be removably snap supported by thedressing. The stud connectors can also be used to create an electricalconnection between one or more batteries and the pump assembly and,accordingly, can be used to activate the pump.

The press studs or snap connectors can allow the one or more batteriesto be electrically disconnected from the pump assembly until one or bothof the components is snapped into the snap connectors. Additionally, ifthere are two or more batteries, such batteries can also have stud typeelectrically conductive connectors that permit the batteries to beseparately supportable by the dressing so that the power circuit can becompleted by snapping each of the one or more batteries into thedressing. In this configuration, the batteries and/or pump assembly canbe snapped into position following sterilization of the dressing kit.Such assembly can also serve to activate the pump.

Additionally, any of the dressing embodiments disclosed herein can beconfigured to support one or more power source modules or pumpassemblies on or adjacent to the dressing. For example, having amultiple number of power sources (e.g., a plurality of batteries, or anycombination of batteries, fuel cells, capacitors, and photovoltaiccells) can improve the flexibly and conformability of the dressing andcan reduce the profile of the dressing. The dressing can be configuredsuch that the batteries are replaceable or interchangeable with similaror different batteries, selectable depending on the duration of time thedressing is to be on the patient. In configurations wherein the powersource is preferably removable, the power source can be snapped into thedock or otherwise removably attachable and detachable from the dressingand configured to be lifted out of the dock or otherwise removed fromthe dressing when it is time to either disposed of or replace thebatteries or power source.

The batteries can be positioned within or supported by the docks priorto positioning the dressing on the patient's body. In embodiments usingconductive connectors fixed to the dressing and or the pump assembly,starting or restarting the pump can be achieved by inserting orre-inserting the one or more batteries in the docks, so as to permit auser to control an operation of the pump by inserting or re-insertingthe batteries.

FIGS. 21A-21C illustrate another dressing kit embodiment 370 having apump assembly 374 and a power source 376 supported on either of adressing member 372 or a separate support member. In some embodiments,the dressing member 372 can have a depression 373 therein configured toreceive the pump assembly 374 and/or power source 376. With reference toFIGS. 21A-21C, in any embodiments disclosed herein, one or morebatteries can be supported in a removable cartridge configured to beremovably engageable with a housing 377 surrounding at least a portionof the power source 376. In some embodiments, the housing 377 can alsosupport or surround the pump assembly 374. With reference to FIG. 21B,in some embodiments, the housing 377 used to support the power source376 can have a lid, cover, or hatch 379 that can be opened to access thepower source 376, which can be batteries.

In some embodiments, the hatch 379 can have one or more batteryterminals or electrical connections thereon configured such that, duringsterilization or before the pump is to be activated, the batteryterminals are out of contact with the power source 376. Aftersterilization or before therapy is to be initiated, the hatch can beclosed to create an electrical connection between the power source 376and the pump assembly 374, thereby initiating the negative pressurewound therapy.

FIG. 22 illustrates another dressing kit embodiment 390 having a pumpassembly 394 and a power source 396 supported on either of a dressingmember 392 or a separate support member. With reference to FIG. 22,similar to the dressing kit embodiment 370, in any embodiments disclosedherein, one or more batteries can be supported in a removable cartridgeconfigured to be removably engageable with a housing 397 supported bythe dressing member 392. In some embodiments, the housing 397 can alsosupport or surround the pump assembly 394 if desired. However, in someembodiments, as in the illustrated embodiment, the pump assembly 394 canbe separately supported by the dressing member 392. The dressing kit 390can be configured such that the power source can be removable anddisposed of and/or replaceable with a replacement power source whendesired. For example, any of the dressing kits disclosed herein can comewith a first power source and a second power source that can be usedsequentially.

FIG. 23 illustrates an embodiment of a dressing kit 410 having a supportlayer 412, a pump assembly 414, a power source 416, and a housing orsupport member 418 configured to support the power source 416 and/or apump assembly 414. In some embodiments, the power source 416 can beremovably attachable to or engageable with the support member 418. Thesupport member 418 can be configured to have conductive terminals suchthat, when the power source 416 is engaged therewith, power isautomatically provided to the pump assembly 414 to either provide thepower to the pump assembly 414 (but requiring a switch or button toactivate the pump assembly) or to power and activate the pump assembly414 to initiate negative pressure. Additionally, in some embodiments,multiple batteries or sources of power can be provided with the dressingkit 410. For example, a first battery pack 416 and a second battery pack416 can be provided with the dressing kit 410 to provide interchangeablepower sources. In some embodiments, the support member 418 can beattached directly to a dressing backing layer, or can be attached to aseparate support layer, such as support layer 412, to enable the pumpassembly and the power source to be attached adjacent to the wound andthe dressing member positioned over the wound.

As an example, as illustrated in FIG. 23, one or more batteries can besupported in a removable cartridge or carrier 420 configured to beremovably engageable with a housing 418 supported by the support layer412. In some embodiments, the housing 418 can also support or surroundthe pump assembly 414 if desired. However, in some embodiments, as inthe illustrated embodiment, the pump assembly 414 can be separatelysupported by the support layer 412. The dressing kit 410 can beconfigured such that the power source can be removable and disposed ofand/or replaceable with a replacement power source when desired. Any ofthe dressing kits disclosed herein can come with a first power sourceand a second power source that can be used sequentially.

With reference to FIG. 23C, the dressing can be configured such thatsliding the batteries into engagement with the battery terminals (in thedirection indicated by arrow A1 in the figures) will result in anaudible click, to alert a user regarding the position of the componentsof the battery enclosure that the battery circuit is closed. Any of thedressing kit embodiments disclosed herein can be supported in packagingconfigured such that, while the dressing kit is supported in thepackaging, the components of the battery pack or pump assembly are heldin a first or non-operational position and prevented from moving to asecond operational position. In this configuration, when the componentsare in the first position, the pump is non-operational due to the factthat the battery terminals are not in contact with the one or morebatteries. For example, the packaging supporting the dressing kit canprevent a lid of the battery housing from moving to the second positionby holding the housing lid or cap in the first position. The packagingcan have protrusions that are positioned between the housing lid or capand the body of the battery housing that separate the battery housinglid from the body of the battery housing. Once the dressing kit isremoved from the packaging, the battery housing lid or cartridge can beslid inward, permitting the terminals to contact the batteries so thatthe pump can be activated. In this configuration, the battery housingcan serve as an activation button. Sliding the lid out of contact fromthe batteries can stop the operation of the pump.

The dressing kit 430 embodiment of FIG. 24 is similar to the dressingkit 410 embodiment of FIG. 23, having a slideable carriage 420configured to move the power source 436 in contact with the pumpassembly 434. Additionally, the dressing kit 430 can have a flexiblehinge 442 positioned between the housing used to support the powersource and pump assembly, and the absorption and/or transmission layers433 of the dressing 432 to permit greater flexibility and conformabilityof the dressing 432.

Additionally, with reference to FIG. 25, in some embodiments, thedressing kit 450 can have a dressing 452, a pump assembly 454, a powersupply 456, and a support member 462 configured to support the pumpassembly 454 and the power supply 456. The support member 462 can besupported by the dressing member 452 and can enable the power supply 456to be removably supported by the dressing member 452. In someembodiments, the power supply 456 can be supported in a carriage 460hingeably supported by the support member 462 or having an adhesivecover that can hold the power supply in the desired position within thesupport member 462.

FIG. 26 illustrates another embodiment of a dressing kit 470 having adressing 472, a pump assembly 474, a power supply 476, and a supportmember 482 configured to support the pump assembly 474 and/or the powersupply 476. The support member 482 can be supported by the dressingmember 472 and can enable the power supply 476 to be removably supportedby the dressing member 472. In some embodiments, the power supply 476can be supported by an adhesive strap 476 having one end thereoffastened or secured to the support member 482. The adhesive strap 476can be sealingly closed over the support member 482 to provide amechanism for holding the power source 476 in the support member 482.The strap can have a tabbed portion for grasping, and can be flexibleenough to deflect away from the dressing when the user wishes towithdraw the battery. The adhesive strap can be colored and/or labeledto alert a user that the batter should be removed before the medicaldevice is incinerated or otherwise disposed of. In some embodiments, asillustrated in FIG. 26C, the power source can be positionable in acompartment in the support member 482 and not attached to the strap 476.

In the embodiment of the dressing 490 illustrated in FIG. 27, the pumpassembly 494 and the power source 496 can be positioned at opposite endsor on different portions of the dressing 492. For example, the pumpassembly 494 and the power source 496 can be adjacent to opposite edgesof the absorption and/or transmission layers 493. As shown in FIG. 27A,the pump 494 and power source 496 modules can be positioned at oppositecorners of the dressing 492. The circuitry used for this arrangement orany other dressing kit embodiments disclosed herein can be flexible sothat the dressing 492 is conformable and flexible to the user.

With reference to the dressing kit 510 embodiment illustrated in FIG.28, the pump assembly 514 can be supported on an edge portion of thedressing 512. A support member 518 can be used to support either or bothof the pump assembly 514 and the power source 516. An overhang orextended portion 518 a can extend over or overlap an adjacent portion ofthe dressing 512 having the absorptive and or transmission layers 513.In some embodiments, as in FIG. 28A, the overhang 518 a can have acurved and smooth profile. In some embodiments, as in FIG. 28C, theoverhang 518 b can have a straight and flexible profile. The overhang orextended portion 518 a can extend over the adjacent edge portion of thedressing to provide a more integrated look and feel

With reference to the dressing kit 530 embodiment illustrated in FIG.29, the pump assembly 534 can be supported on an edge portion of thedressing 532. A support member 540 can be used to support either or bothof the pump assembly 534 and the power source 536. An overhang orextended portion 540 a can extend over or overlap an adjacent portion ofthe dressing 532 having the absorptive and or transmission layers 533.In some embodiments, as in FIG. 28A, the overhang 538 a can have acurved and smooth profile. Additionally, in some embodiments, a joint orflexible hinge 538 can be positioned between the pump assembly 534 andthe power source 536. The overhang or extended portion 540 a can extendover the adjacent edge portion of the dressing to provide a moreintegrated look and feel.

FIG. 30 illustrates an embodiment of a dressing kit 550 having a supportlayer 552, a pump assembly (not illustrated), a power source 556, and ahousing or support member 558 configured to support the power source 556and/or a pump assembly 554. In some embodiments, the power source 556can be removably attachable to or engageable with the support member558. The support member 558 can be configured to have conductiveterminals such that, when the power source 556 is engaged therewith,power is automatically provided to the pump assembly 554 to eitherprovide the power to the pump assembly 554 (but requiring a switch orbutton to activate the pump assembly) or to power and activate the pumpassembly 554 to initiate negative pressure. Additionally, in someembodiments, multiple batteries or sources of power can be provided withthe dressing kit 550. For example, a first battery pack 556 and a secondbattery pack 556 can be provided with the dressing kit 550 to provideinterchangeable power sources. In some embodiments, the support member558 can be attached directly to a dressing backing layer, or can beattached to a separate support layer, such as support layer 552, toenable the pump assembly and the power source to be attached adjacent tothe wound and the dressing member positioned over the wound.

Further, one or more batteries 556 can be supported in a removablecartridge or carrier 560 configured to be removably engageable with ahousing 558 supported by the support layer 552. In some embodiments, thehousing 558 can also support or surround the pump assembly 554 ifdesired. However, the pump assembly 554 can be separately supported bythe support layer 552. The dressing kit 550 can be configured such thatthe power source can be removable and disposed of and/or replaceablewith a replacement power source when desired. Any of the dressing kitsdisclosed herein can come with a first power source and a second powersource that can be used sequentially.

With reference to FIG. 30, the dressing can be configured such thatsliding the batteries into engagement with the battery terminals (in thedirection indicated by arrow A1 in the figures) will result in anaudible click, to alert a user regarding the position of the componentsof the battery enclosure that the battery circuit is closed. Any of thedressing kit embodiments disclosed herein can be supported in packagingconfigured such that, while the dressing kit is supported in thepackaging, the components of the battery pack or pump assembly are heldin a first or non-operational position and prevented from moving to asecond operational position. Optional position and prevented from movingto a second operational position. In this configuration, when thecomponents are in the first position, the pump is non-operational due tothe fact that the battery terminals are not in contact with the one ormore batteries. For example, the packaging supporting the dressing kitcan prevent a lid of the battery housing from moving to the secondposition by holding the housing lid or cap in the first position. Thepackaging can have protrusions that are positioned between the housinglid or cap and the body of the battery housing that separate the batteryhousing lid from the body of the battery housing. Once the dressing kitis removed from the packaging, the battery housing lid or cartridge canbe slid inward, permitting the terminals to contact the batteries sothat the pump can be activated. In this configuration, the batteryhousing can serve as an activation button. Sliding the lid out ofcontact from the batteries can stop the operation of the pump.

FIG. 31 illustrates a dressing kit 570 having a dressing member 572, apower source 576 positioned within a support member 578, and a hingedlid 580 hingably positioned over an opening in the support member 578.The lid 580 can rotate about an axis or joint 582. In some embodiments,the hinge can be configured such that, when the hinge is moved to aclosed position, the power source 576 will be secured within the supportmember 578 and an electrical connection will be created between thepower source 576 and a pump assembly (not illustrated) so that the pumpcan be changed to an operational state. The hinged door can have aliving hinge, soft pivot, an axle, or other suitable mechanism.

In some embodiments, as illustrated in FIG. 32, the dressing kit 590 canhave a housing 598 made from a resilient, thin-walled material having anopening 599 therein can be used to hold the power source 596 within thehousing 598. The power source 596 can be squeezed through the opening599 with sufficient force to cause the opening 599 to widen sufficientlyto permit the passage of the power source therethrough. Thereafter,being formed of a resilient material, the opening in the housing canreduce in size, thereby securely holding the power source 596 within thehousing 598. A plug connection 600 can be used to electrically connectthe power source to the pump assembly.

FIG. 33 illustrates an embodiment of a dressing kit 610 having adressing member 612, a pump assembly 614, a power source 616, and ahousing or support member 618 configured to support the power source 616and/or a pump assembly 614. In some embodiments, the support member 618can be configured to pass through an opening 613 in a bottom or baseportion of the dressing member 612 so that the power source 616 and/orthe pump assembly 614 are positioned within the opening 613. A coverlayer 615, which can be removable or hingably attached to the dressingmember 612, can be positioned over a top surface of the power supply616, pump assembly 614, and/or the support member 618. In someembodiments, the power source 616 and the pump assembly 614 can bepositioned within the dressing member 612 so as to be flush or beneath atop surface 612 a of the dressing member 612.

The battery and/or pump module can be loaded from the bottom to give thedressing a more integrated look and feel. Further, the device could bepositioned beneath the backing layer (i.e., outermost layer away fromthe wound).

In some embodiments, the dressing kit 610 can be configured to haveconductive terminals such that, when the power source 616 is engagedtherewith or positioned within the opening 613, power is automaticallyprovided to the pump assembly 614 from the power source 616 to eitherprovide the power to the pump assembly 614 (but requiring a switch orbutton to activate the pump assembly) or to power and activate the pumpassembly 614 to initiate negative pressure. A bottom layer 617 can beused to secure the housing and/or power source in the opening 613 on abottom or base surface of the dressing member 612.

Multiple batteries or sources of power can be provided with the dressingkit 610. For example, a first battery pack 616 and a second battery pack616 can be provided with the dressing kit 610 to provide interchangeablepower sources. In some embodiments, the support member 618 can beattached directly to a dressing backing layer, or can be attached to aseparate support layer, such as support layer 612, to enable the pumpassembly and the power source to be attached adjacent to the wound andthe dressing member positioned over the wound.

In some embodiments, the housing 618 can also support or surround thepump assembly 614 if desired. However, the pump assembly 614 can beseparately supported by the support layer 612. The dressing kit 610 canbe configured such that the power source can be removable and disposedof and/or replaceable with a replacement power source when desired. Anyof the dressing kits disclosed herein can come with a first power sourceand a second power source that can be used sequentially. In someembodiments, the cover layer over the top of the dressing member 612 canform a continuous layer over the opening 613 such that a separate covertab or layer 615 is not required. The cover layer over the top of theopening can be perforated or porous to permit air exhausted from thepump to exit the dressing.

FIG. 34 illustrates an embodiment of a dressing kit 630 having adressing member 632, a pump assembly (not illustrated), a power source636, and a support layer 638 configured to support the power source 636and/or a pump assembly 634. In some embodiments, the support layer 638can be configured to cover an opening 633 in the dressing member 632 sothat the power source 636 and/or the pump assembly 634 are positionedwithin the opening 633. In some embodiments, the power source 636 andthe pump assembly 634 can be positioned within the dressing member 632so as to be flush or beneath a top surface 632 a of the dressing member632.

In some embodiments, the dressing kit 630 can be configured to haveconductive terminals such that, when the power source 636 is engagedtherewith or positioned within the opening 633, power is automaticallyprovided to the pump assembly 634 from the power source 636 to eitherprovide the power to the pump assembly 634 (but requiring a switch orbutton to activate the pump assembly) or to power and activate the pumpassembly 634 to initiate negative pressure.

Additionally, in some embodiments, multiple batteries or sources ofpower can be provided with the dressing kit 630. For example, a firstbattery pack 636 and a second battery pack 636 can be provided with thedressing kit 630 to provide interchangeable power sources. In someembodiments, as shown in FIG. 34C, the cover layer 638 can have anopening 639 therein, the opening being configured to permit the removalof the power supply 636 from the opening or compartment 633 whendisposal or replacement of the power supply is desired.

The pump assembly can also be supported within the opening 633 and canbe covered by the cover layer 638. The cover layer 638 can be perforatedto permit exhaust gas to exit the opening or compartment 633. In someembodiments, the cover layer over the top of the dressing member 632 canform a continuous layer over the opening 633 such that a separate covertab or layer 638 is not required. The cover layer over the top of theopening can be perforated or porous to permit air exhausted from thepump to exit the dressing.

FIG. 35 illustrates another embodiment of a dressing kit 650 having adressing member 652, a pump assembly (not illustrated), a power source656, and a support layer 658 configured to support the power source 656and/or a pump assembly 654 over the cover layer 653 of the dressing. Insome embodiments, the support layer 658 can be configured to cover thepower source 656 and/or the pump assembly 654. The support layer 658 canhave a tabbed portion 658 a configured to permit a user to grasp thesupport layer 658 for removal thereof. The support layer 658 can befastened to the top layer 653 of the dressing member 652 using adhesive659. When the power source 656 is desired to be removed for replacementor disposal, a user can grasp the support layer 658 by the tabbedportion 658 a and lift the support layer 658 off of the power source656. In some embodiments, where a pump assembly 654 can be supportedunder the support layer 658, an opening 660 formed in the upper layer653 of the dressing member 652 can permit the passage of gas from withinthe dressing member or between the dressing member and the wound to passthrough the pump assembly 654 and out of the dressing kit 650.

In some embodiments, the dressing kit 650 can be configured to haveconductive terminals such that, when the support layer 658 is closedagainst the upper layer 653 of the dressing 652 on both sides of thepower source 656, power is then provided to the pump assembly 654 fromthe power source 656 to either provide the power to the pump assembly654 (but requiring a switch or button to activate the pump assembly) orto power and activate the pump assembly 654 to initiate negativepressure.

Additionally, in some embodiments, multiple batteries or sources ofpower can be provided with the dressing kit 650. For example, a firstbattery pack 656 and a second battery pack 656 can be provided with thedressing kit 650 to provide interchangeable power sources. The coverlayer 658 can be perforated to permit exhaust gas to exit through thecover layer 658. In some embodiments, the cover layer over the top ofthe dressing member 652 can form a continuous layer over the opening 653such that a separate cover tab or layer 658 is not required.

As illustrated in FIG. 36, some embodiments of the dressing kit 650 canhave multiple support layers were release tabs 658 used to releasablyfasten the pump assembly 654 and/or the power source 656 to thedressing. For example, as illustrated in FIG. 36, a first tab 658 a andthe second tab 658 b can be positioned on mutually opposing ends of ahousing used to support the pump assembly 654 and the power supply 656.

Furthermore, in some embodiments, the dressing kit can have a tearablestrap covering at least one of a pump assembly and a power source thatcan be perforated or slit to facilitate the tearing of the strap.Additionally, the strap could be non-tearable but could be adhered tothe supporting surface using Velcro or other similar adhesive materials.With some embodiments of the pull-tab arrangement, the batteries can beremoved by pulling on a label or pull tab. This can be achieved witheither side or end ejection. As illustrated in FIG. 37, the cover layer658 of some embodiments of the dressing kit 650 or any other dressingkit disclosed herein can have one or more perforated or tearableportions 661 configured to tear open to permit the removal of the pumpassembly 654 and/or the power source 656. A tab 663 can be grasped toinitiate the tear.

FIG. 38 illustrates another embodiment of a dressing kit 670 having adressing member 672, a pump assembly 674, and a power source 676. In anyof the dressing kit embodiments disclosed herein, the dressing member672 can but is not required to have a wound contact layer 680, one ormore layers of spacer material 682 (also referred to herein as atransmission layer or layers), one or more layers of absorbent material684, and a cover layer (not illustrated) configured to cover at leastthe layer of spacer material 682 and the layer of absorbent material682. Additionally, in any of the embodiments disclosed herein, the powersource can have a flexible battery 676 configured to cover a portion ofthe absorption and transmission layers.

In some embodiments, the flexible battery 676 can have a plurality ofdifferent material layers coupled with one another. For example, in someembodiments, the flexible battery 676 can have a current collector layer690, above an anode layer 692, followed by a separator layer 694, thecathode layer 696, and finally a current collector layer 698 on thebottom thereof. Additionally, any embodiments of the dressing kitdisclosed herein can be powered by one or more flexible printedbatteries based on the technology developed by Imprint Energy, or by oneor more carbon zinc flexible batteries manufactured by Blue SparkTechnologies, built, such as any of those described above. The size ofthe flexible battery 676 can depend on the power requirements of thepump assembly and duration desired for the negative pressure woundtherapy. In some embodiments, however, the flexible battery 676 can beapproximately the same size as the absorption layers in the dressing andcan be configured to cover the absorption layers in the dressing.

Further, in any of the dressing kit embodiments disclosed herein, suchas dressing kit 670, the pump assembly 674 can be controlled by aflexible control board. Further, any dressing kit embodiments disclosedherein can further have an organic light emitting diode (“OLED”) displayor other suitable interface display.

FIG. 39 is an illustration of another embodiment of a dressing kit 710configured to be positioned over a wound. The dressing kit 710 can haveany of the features of any other dressing kits disclosed herein. In someembodiments, the dressing kit 710 can have a dressing member 712 a pumpassembly 714 powered by a flexible PCB 715, and plurality of powersources 716 position about the dressing member 712. For example, in someembodiments, each of the power sources 716 can be a flexible batterysuch as a flexible printed battery, a thin lithium battery, aphotovoltaic cell, and/or any other suitable power source. The pluralityof power sources 716 can be interconnected by electrical wiring 722 inany suitable configuration or arrangement to permit the optimal level ofcurrent flow and voltage to the pump assembly. The electrical wiring 722can be connected to the control board 715 configured to control anoperation of the pump assembly 714.

FIG. 40 illustrates another embodiment of a dressing kit 750 having adressing member 752, a pump assembly 754, and a power source 756. Thedressing kit can be packaged with the pump assembly 754 and the powersource 756 positioned on top of the dressing member 752. The dressingkit 750 is configured such that the pump assembly 754 and the powersource 756 can remain positioned above the dressing member duringtreatment. Or, alternatively and at the user's preference, releasablebacking layer 760 can be removed from the pump assembly 754 and thepower source 756 so that the pump assembly 754 and the power source 756can be flipped or folded out and adhere to the skin adjacent to thewound dressing member 752. A conduit can communicate the negativepressure generated by the pump assembly 754 to the dressing member 772and/or to the space between the dressing member 772 and the wound.

FIG. 41 illustrates another embodiment of a dressing kit 770 having adressing member 772, a pump assembly 774, and a power source 776. Thedressing kit can be packaged with the pump assembly 774 and the powersource 776 positioned on top of the dressing member 772. The dressingkit 770 is configured such that the pump assembly 774 and the powersource 776 can remain positioned above the dressing member duringtreatment. Or, alternatively and at the user's preference, releasablebacking layer 780 can be removed from the pump assembly 774 and thepower source 776 so that the pump assembly 774 and the power source 776can be flipped or folded out and adhere to the skin adjacent to thewound dressing member 772. A flexible conduit 778 can communicate thenegative pressure generated by the pump assembly 774 to the dressingmember 772 and/or to the space between the dressing member 772 and thewound. A film layer 775 adhered to a surface of the power source or thepump assembly, or a non-conductive material separating electricalconnections between the power source and the pump assembly can beremoved to activate the pump assembly.

In any embodiments disclosed herein, including the embodimentillustrated in FIG. 41, the conduit 778 can have a foam, a transmissionlayer or 3d knit fabric, and/or other porous material therein to preventor significantly prevent the collapse of the conduit during operationfrom kinking, crushing, etc., while permitting the passage of fluidstherethrough. For example and without limitation, in any embodimentsdisclosed herein, the conduit can have a top and a bottom layerconstructed from a liquid impermeable material, a 3D knitted or 3Dfabric material located between the top and bottom layers, an opening influid communication with the 3D knitted or 3D fabric material, and anelongate channel extending between the top and bottom layers containingthe 3D knitted or 3D fabric material. The opening can be in fluidcommunication with any of the transmission and/or absorption layerswithin the dressing member. In any embodiments disclosed herein, theconduit can be integrally formed with the remainder of the dressingmember. Additionally, in any embodiments disclosed herein, the conduitcan have a width from approximately 0.5 inches or less to approximately0.75 inches or more, from approximately 0.75 inch to approximately 1.5inches or more, having a low profile height of from approximately 0.1 orless to approximately 0.25 or more inches.

FIG. 42 illustrates another embodiment of a dressing kit 790 having adressing member 792, a pump assembly 794, and a power source 796. Thedressing kit can be configured such that the pump assembly 794 and thepower source 796 are supported within a module 795 that is rotatable anaxis. In some embodiments, the axis of rotation can be coincident with aport member 800 configured to communicate the negative pressuregenerated by the pump assembly to the dressing. Thus, in someembodiments, the dressing kit 790 can be configured such that thebattery 796 and/or pump assembly 794 are pivotably positionable on thedressing so that the position and/or orientation of the battery moduleand/or pump assembly can be adjusted or adjustable depending on thecontour of the body. Additionally, a second sealable port 802 can beformed in the top layer of the dressing member 792 to permit the user toselect which port to use for the pump assembly 794. An angularorientation of the module 795 can be adjusted in position from a firstorientation to a second orientation. In the first orientation, themodule 795 can be positioned along a lengthwise edge or a first edge ofthe dressing member 792. In a second orientation, the module 795 can bepositioned along a short edge or a second edge of the dressing member792. Additionally, the module 795 can be positioned at any desiredorientation between the first and second positions or orientations.

FIG. 43 illustrates another embodiment of a dressing kit 810 having adressing member 812 having one or more absorption and/or transmissionlayers 813, a pump assembly 814, and a power source 816. The embodimentillustrated in FIG. 43 can have a length of conduit 818 between the pumpand the dressing that permits the dressing to be mounted adjacent to oron top of the dressing. The dressing kit can be packaged with the pumpassembly 814 and the power source 816 positioned on top of the dressingmember 812 or adjacent to the dressing member. The dressing kit 810 isconfigured such that the pump assembly 814 and the power source 816 canremain positioned above the dressing member during treatment, beingadhered or removably fastened to the top of the dressing using a Velcro,adhesive, one or more clips, a pouch, or otherwise. Or, alternativelyand at the user's preference, the pump assembly 814 and/or the powersource 816 can be moved away from the wound so that the pump assembly814 and the power source 816 can be positioned remote to the dressing812. For example, the pump assembly 814 and/or the power source 816 canbe adhered to the skin adjacent to the wound dressing member 812.

A flexible conduit 818 can communicate the negative pressure generatedby the pump assembly 814 to the dressing member 812 and/or to the spacebetween the dressing member 812 and the wound. In any embodimentsdisclosed herein, including the embodiment illustrated in FIG. 43, theconduit 818 can have a foam, a transmission layer or 3d knit fabric,and/or other porous material therein to prevent or significantly preventthe collapse of the conduit during operation from kinking, crushing,etc., while permitting the passage of fluids therethrough. In someembodiments, with reference to FIGS. 43C-43E, the conduit 818 cancomprise a small sheet of a transmission material forming a conduitbetween the pump assembly 814 and the absorption material 812. In thisarrangement, the transmission material can have a foam, a transmissionlayer or 3d knit fabric, and/or other porous material therein to preventor significantly prevent the collapse of the conduit during operationfrom kinking, crushing, etc., and can have a cross-sectional areatransverse to the flow direction that is approximately one-third thewidth of the absorption and/or transmission layers 813, or fromapproximately one-quarter to approximate one-half the width of theabsorption and/or transmission layers 812. This extra width of theconduit 818 can help prevent blockage of the conduit that may affect thetransmission of reduced pressure to the dressing layers 813.

In any embodiments, the dressing layers 813, pump assembly 814, thepower source 816, and the conduit 818 can be supported by the dressingmember 812. Additionally, the conduit 818 can have any of the materials,features, or other details of any of the other conduit arrangementsdisclosed herein.

FIG. 44 illustrates another embodiment of a dressing kit 830 having adressing member 832 having one or more absorption and/or transmissionlayers 833, a pump assembly 834, and a power source 836. The dressingkit can be packaged with the pump assembly 834 and the power source 836positioned adjacent to one or more absorption and/or transmission layers833 but being removably attached to the dressing member 832 supportingthe one or more absorption and/or transmission layers 833.

The dressing kit 830 can be configured such that the pump assembly 834and the power source 836 can remain positioned adjacent to the dressingmember 832 during treatment. Or, alternatively and at the user'spreference, the pump assembly 834 and the power source 836 can bepositioned on a portion of the dressing member 832 that can be detachedfrom the portion of the dressing member 832 supporting the one or moreabsorption and/or transmission layers 833. For example, in someembodiments, the one or more absorption and/or transmission layers 833can be positioned on a first portion 832 a of the dressing member 812,and the pump assembly 834 and the power source 836 can be positioned ona second portion 832 b of the dressing member 832 that can be detachedfrom the first portion 832 a of the dressing member 832. In someembodiments, the dressing member 832 can have a perforation,indentations, reduced thickness, or one or more cutouts between thefirst portion 832 a and the second portion 832 b of the dressing member832 to facilitate the detachability of the first portion 832 a from thesecond portion 832 b of the dressing. This can facilitate the detachmentof the second portion 832 b of the dressing 832 from the first portion832 a of the dressing for placement of the second portion 832 b of thedressing 832 in a desired location spaced apart from the first portion832 a of the dressing, and hence, spaced apart from the wound. Thesecond portion 832 b of the dressing member 832 can have a differentadhesive thereon as compared to the adhesive on the first portion 832 aof the dressing member 832 for adhesion to the skin or otherwise.

A flexible conduit 838 can communicate the negative pressure generatedby the pump assembly 834 to the dressing member 832 and/or to the spacebetween the dressing member 832 and the wound. A film layer adhered to asurface of the power source or the pump assembly, or a non-conductivematerial separating electrical connections between the power source andthe pump assembly can be removed to activate the pump assembly.

In any embodiments disclosed herein, including the embodimentillustrated in FIG. 44, the conduit 838 can have a foam, a transmissionlayer or 3d knit fabric, and/or other porous material therein to preventor significantly prevent the collapse of the conduit during operationfrom kinking, crushing, etc., while permitting the passage of fluidstherethrough, and can have a width from approximately 0.5 inches or lessto approximately 0.75 inches or more, from approximately 0.75 inch toapproximately 1.5 inches or more, having a low profile height of fromapproximately 0.1 or less to approximately 0.25 or more inches.

FIG. 45 illustrates another embodiment of a dressing kit 850 having adressing member 852, a pump assembly 854, and a power source 856. Insome embodiments, the dressing kit 850 can have any of the features,details, or components of any of the other dressing kit embodimentsdisclosed herein. In any dressing kit or pump assembly embodimentsherein, including the embodiment of the dressing kit 850 shown in FIG.45, the pump assembly can have one or more indicator lights (such as LEDindicator lights), and one or more control buttons or switches. Thedressing kit can be packaged with the pump assembly 854 and the powersource 856 positioned adjacent to the dressing layers 853. The dressingkit 850 can be configured such that the pump assembly 854 and the powersource 856 can remain positioned adjacent to the absorption and/ortransmission layers 853 (collectively referred to as the dressinglayers) during treatment. Or, alternatively and at the user'spreference, the pump assembly 854 and the power source 856 can bepositioned on a portion of the dressing member 852 that can be detachedfrom the portion of the dressing member 852 supporting the one or moreabsorption and/or transmission layers 853.

For example, in any dressing kit embodiments disclosed herein, the oneor more absorption and/or transmission layers 853 can be positioned on afirst portion 852 a of the dressing member 812, and the pump assembly854 and the power source 856 can be positioned on a second portion 852 bof the dressing member 852 that can be detached from the first portion852 a of the dressing member 852. Additionally, in any embodimentsdisclosed herein, the conduit 858 can be positioned on a third portion852 c of the dressing member 852 that can be detached from the firstportion 852 a of the dressing member 852 and/or the second portion 852 bof the dressing member 852.

In any embodiments, the dressing member 852 can have one or moreintermittent or continuous scores, perforation, indentations, notches,cuts, cutouts, partial thickness cuts, or reduced thickness 855 betweenthe first portion 852 a and the second portion 852 b of the dressingmember 852, between the second portion 852 b and the third portion 852 cof the dressing member 852, and/or between the first portion 852 a andthe third portion 852 c of the dressing member 852 to facilitate thedetachability of the first portion 852 a from the second portion 852 bof the dressing member 852. This can facilitate the detachment of thesecond portion 852 b of the dressing member 852 from the first portion852 a of the dressing member for placement of the second portion 852 bof the dressing 852 in a desired location spaced apart from the firstportion 852 a of the dressing, and hence, spaced apart from the wound.The second portion 852 b of the dressing member 852 can have a differentadhesive thereon as compared to the adhesive on the first portion 852 aof the dressing member 852 for adhesion to the skin or otherwise.Further, as with any embodiments disclosed herein, the pump assembly 854can have pull tabs or strips configured to activate the pump or permitthe conduction of current from the power source to the pump assembly.

Additionally, as illustrated in FIG. 45, a conduit 858 can communicatethe negative pressure produced by the pump assembly 858 to the dressinglayers 853. The conduit can be attached to or formed as part of thedressing cover layer used to cover the dressing layers 813. In someembodiments, at least one of an outer or top layer used to form theconduit in any embodiments disclosed herein can be vapor permeable. Inthis configuration, the conduit 858 can be sealed along a length thereofand can have perforations along the length thereof so that any desiredlength of conduit 858 can be detached from the dressing member 852, withthe remaining portion of the conduit 858 remaining attached to thedressing member 852, as illustrated in FIG. 45B.

For example, in some embodiments, as illustrated in FIG. 45A, thedressing member 852 have a plurality of perforations, including withoutlimitation first perforation 855 a, second perforation 855 b, thirdperforation 855 c, and so on. A user can tear and detach the conduit 858along any desired number of the perforations to permit any desiredlength of conduit 858, while the remaining portion of the conduitremains removably attached to the dressing member 852. In anyembodiments, the perforations 855 can be arranged in a parallelorientation, as illustrated in FIGS. 45A and 45B. Alternatively oradditionally, one or more perforations 855 can be arranged about aperimeter of the dressing member 852, which can surround the dressinglayers 853, as illustrated in FIG. 45C.

Additionally, with reference to FIG. 45C, the dressing member 852 cansupport a plurality of power sources (which can be any of the flexiblebattery or any other power source embodiments disclosed herein) 856distributed about a first portion 852 a of the dressing member 852,either under, within or on top of any of the layers, materials, ormembers comprising the dressing layers 853 or dressing member 852. Thepower sources 856 can be interconnected in any desired fashion using oneor more electrical connectors or wires 857. In some embodiments, thewire connectors 857 can extend along or within the conduit 858 toprovide power to the pump assembly 854 located on the second portion 852b of the dressing member 852. The pump assembly 854 in any embodimentsdisclosed herein, including dressing kit embodiment 850, can be aminiature pump have a voice coil, a diaphragm, or otherwise.

In any embodiments disclosed herein, including the embodimentillustrated in FIG. 45, the conduit 858 can have a foam, a transmissionlayer or 3d knit fabric, and/or other porous material therein to preventor significantly prevent the collapse of the conduit during operationfrom kinking, crushing, etc., while permitting the passage of fluidstherethrough, and can have a width from approximately 0.5 inches or lessto approximately 0.75 inches or more, from approximately 0.75 inch toapproximately 1.5 inches or more, having a low profile height of fromapproximately 0.1 or less to approximately 0.25 or more inches.

In any embodiments disclosed herein, the conduit can be formed of twolayers of liquid and air impervious material (such as a thin polymerfilm) and have one or more layers of foam or other porous material toprevent the conduit from collapsing, formed in a circular, square, orother shaped length of material having foam or other porous materialtherein. As such, the dressing can be configured such that a user canadjust the length of the conduit by the amount of the conduit removedfrom the dressing.

Additionally, with reference to the dressing kit embodiment 870illustrated in FIG. 46, in any of the embodiments disclosed herein, thedressing kit can have a conduit 878 that is arranged in a spiral orhelical arrangement adjacent to the one of more dressing layers 873 ofthe dressing member 872. The conduit can be spirally wound about thepump assembly and/or power source. In some embodiments, the dressing kit870 can have any of the features, details, or components of any of theother dressing kit embodiments disclosed herein, including withoutlimitation those of dressing kit 850, including without limitation anyof the details regarding the power source, pump assembly, dressingmember, or conduit described with respect to any of the otherembodiments, such as for dressing kit 850. For example, in someembodiments, the conduit can be perforated along a length thereof forselective detachment from the dressing member 872.

In any of these arrangements, the conduit 878 can be unwound or extendedto permit the user to select the appropriate length of the conduit 878.The dressing can be used in the completely wound up arrangementillustrated in FIG. 45, or can be partially unwound and used with theconduit partially wound up around the pump assembly 878, or the conduit878 can be fully extended such that the pump assembly is positionedapart from the dressing. A bottom surface of the pump assembly can becoated with an acrylic or other suitable adhesive or fastener (such asany of the other fasteners disclosed herein) for attaching the pumpand/or conduit to the body or even to the dressing member 872, asdesired.

FIG. 47 illustrates another embodiment of a dressing kit 890 having adressing member 892, a pump assembly 894, and a power source 896. Insome embodiments, the dressing kit 890 can have any of the features,details, or components of any of the other dressing kit embodimentsdisclosed herein. The dressing kit can be packaged with the pumpassembly 894 and/or the power source 896 positioned adjacent to thedressing layers 893. In some embodiments, the power source can beseparable from the dressing member 892 and positionable in any desiredposition on the dressing member 892 and/or on the body adjacent to thedressing member or wound or otherwise. The power source 896 can beconnected to the pump assembly 894 using a wired connection 897 that canhave a connector for easy removal of the power source 896 for disposalor replacement.

Additionally, the dressing can be configured such that a perforated orweakened band of material is routed around the portion of the dressingthat supports the battery. This can form a detachable portion of thedressing that supports the battery. Such configurations can facilitatebattery removal, replacement, and/or proper disposal. Additionally, thebattery module can be supported on a removable or separate portion ofthe dressing that tape or otherwise adhered to the main portion of thedressing and is easily removed therefrom for easy disposal of thebattery module. The portion of the dressing that can support the batterymodule can be connected to the remaining portion of the dressing bytape, a local pad, or otherwise. The pump can be supported by the maindressing area. This could have a benefit for sterilization orsterilization of particular parts of the dressing, and could permitfrequent (e.g., daily) battery changes. Additionally, in someembodiments, the batteries can be supported in a battery tray that canbe easily supported by the dressing. The battery tray can be configuredto be snapped into and out of the receiving portion of the dressing orpump assembly. This can reduce the wall thickness of the battery moduleand battery compartment.

In the embodiment of the dressing kit 910 illustrated in FIG. 48, thebattery module can have one or more zinc air activated batteries 916 asthe power source for the pump assembly 914. In this arrangement,removing a pull-tab 917 so as to expose the batteries 916 to air willactivate the batteries 916 and start the operation of the pump 914. Thepull-tab or label 917 can cover the openings or air passageways incommunication with the batteries 916 and can be peeled back or removedto activate or re-activate the batteries 916. The pull-tab 917 can beconfigured to cover only a portion of the dressing member 912 or thebattery module 916, or can be integral to larger dressing support foradded stiffness during application of the dressing to the body. Any ofthe dressing kit embodiments disclosed herein can use any of thefeatures, details, or components of the dressing kit 910 therein,including without limitation the air activated batteries.

With reference to FIG. 49, which illustrates a dressing kit 930 having adressing member 932, and a pump assembly having a PCB 933, the powersource or pump assembly can have one or more conductive labels 937 that,when in a first position, do not provide an electrical connectionbetween a first terminal 938 a and a second terminal 938 b supported bythe dressing member 932 or the PCB 933. When the conductive label or tab937 is moved to a second position, the conductive tab 937 can provide anelectrical connection between the first terminal 938 a and the secondterminal 938 b, so as to activate the pump assembly. The packagingsupporting the dressing can be configured such that such conductivelabel is held fixed in the first position to ensure that the batteriesare not electrically connected to the pump assembly or other componentsduring sterilization or prior to application to a patient or user. Theconductive label 937 could be used as a pause button, or to terminatethe operation of the pump.

In any dressing kit embodiments disclosed herein, the dressing kit canhave one or more pull tabs (such as pull tabs 957 illustrated in FIGS.50A-D) configured to activate and deactivate the pump assembly. In thisarrangement, each pull tab 957 can be configured to be positioned, orhave a portion thereof that is positioned, between a first terminal 958a and a second terminal 958 b to selectively control an activation ofthe pump assembly 954. When the pull tab 957 is positioned between thefirst terminal 958 a and the second terminal 958 b, thereby separatingthe first and second terminals 958 a, 958 b, no power will be providedto the pump assembly 954. By retracting the pull tab 957, the first andsecond terminals 958 a, 958 b can be placed in contact with one anothersuch that power can be provided to the pump assembly.

Additionally, in any embodiments, the packaging supporting the dressingkit can be configured such that such tab or isolator is fixedlypositioned between the components in the electrical circuit to ensurethat the batteries are not electrically connected to the pump assemblyor other components during sterilization (if used) or Prior toactivation. For example, as illustrated in FIGS. 50B-50D, a pull tab canbe positioned over any desired surface of the dressing, power supply, orpump assembly, of any of the dressing or pump assembly embodimentsdisclosed herein. As is disclosed in other embodiments, the label or tabcan be conductive such that the first and second terminals are incommunication with one another when the label is connected to bothterminals.

As shown in FIG. 51, in any embodiments disclosed herein, the dressingkit (such as dressing kit 970 disclosed in FIG. 51) can have one or morebuttons 979 supported by the dressing member 972. The buttons 979 can befixed to the backing layer 975 of the dressing member 972 and can bepositioned near an edge portion of the dressing (such as outside of theperimeter of the dressing layers 973) where operation of the buttonswill not irritate or cause discomfort or damage to the wound. Thecontrols can comprise one or more keypad buttons that can be positionedanywhere on the wound. The dressing can have one or more printed cables981 to provide electrical connections between the batteries, activationbuttons, LED or other lights 986 for indicating a condition under thedressing or with regard to the pump assembly 974, and/or power source976.

With reference to the dressing kit 990 shown in FIG. 52, in anyembodiments disclosed herein, the pump assembly 994 can be activatedusing one or more pop buttons 997. Each pop button 997 can be configuredsuch that, when the pump is activated and the conditions under theoverlay are within threshold parameters, the pop button will remaindepressed and the pump will continue to operate. The circuitry of thepump assembly 994 can be configured to maintain the button 997 in thedepressed position during optimal or threshold conditions, for examplewhen a sufficient vacuum has been achieved. The button can be configuredto pop up when a sufficient vacuum has not been achieved, or when otheroperating conditions under the overly are not within the thresholdparameters. As such, the button can be used to provide a visualindication of the operating conditions of the dressing. The button canbe depressed to initially activate operation of the pump.

The switch 1017 (which can be a trip switch) illustrated in FIG. 53 canalso be used to activate or control any of the pump assembly or dressingkit embodiments disclosed herein, and can also provide a visualindication of the operating conditions of the dressing. Depressing theswitch 1017 can activate a pump. The switch 1017 can move between afirst, relaxed position to a second, depressed position.

In some embodiments, the circuitry of the pump can be used to maintainthe switch in the depressed state when the operating conditions underthe backing layer are within threshold parameters. In some embodiments,the switch 1017 can have one or more components made from a shape memorymaterial, or have a memory bistable dome or diaphragm therein that canhold the switch 1017 in a depressed position for a predetermined periodof time during initial pump down until the level of reduced pressureunder the overlay is sufficient to maintain the switch in the depressed(or second) position. In some embodiments, a pressure sensor within thedressing or pump assembly can be configured to provide a current ofelectricity to a shape memory, piezoelectric material sufficient to holdthe switch in the depressed or second position.

The switch can be configured to pop up if there is a leak in thedressing (detected based flow rate through the pump or on duty cyclefeedback or other parameters), or if one or more other parameters orconditions are not met, such as but not limited to insufficient batterypower or insufficient negative pressure within the dressing after apredetermined period of time. For example, the switch of this or anyother embodiment disclosed herein can be configured to move between afirst on position and a second off position, and to remain in the firstposition when a threshold level of negative pressure is maintainedbeneath the backing layer. The switch of this or any other embodimentdisclosed herein can be configured to move to the second position whenthe level of negative pressure under the backing layer is less than athreshold level of negative pressure and the pump assembly exceeds athreshold flow rate for a threshold period of time, which can be causedby the presence of a leak in the system. For example, any of theembodiments disclosed herein can be configured to trigger an alarm orchange the switch or button from a first operational position to asecond non-operational position when the pressure beneath the dressingis less than 60 mmHg (i.e., less meaning 59 mmHg or lower) and the pumpassembly has been operating for a threshold period of time, such as forapproximately 5 minutes, from approximately 5 minutes to approximately 8minutes, or from approximately 2 minutes to approximately 5 minutes, orany values within any of the foregoing ranges. Additionally, depressingthe switch can produce an audible click to alert the user that theswitch has been activated.

The embodiment of the dressing kit 1030 illustrated in FIG. 54 can havea pump assembly 1034 supported on the dressing member 1032. The pumpassembly 1034 can have a flexible activation switch 1037 that canactivate or control any of the pump assembly or dressing kit embodimentsdisclosed herein. The activation switch can be configured to be aflexible tab 1041 having one or more buttons 1039 supported there. Theflexible tab 1041 can be rotated upward away from the pump assembly to afirst position to permit a user to grasp and activate the button orbuttons 1039. In any embodiments disclosed herein, the button 1039 canbe activated by squeezing the button 1039, so that no force or verylittle force is imparted on the wound dressing or wound bed. When in thestowed or second position, the activation switch or tab 1037 can have alow profile and lie substantially flat against the pump assembly.

Alternatively, in any embodiments, the activation switch can be a slideactivation switch (such as slide activation switch 1057 illustrated inFIG. 55 or slide activation switch 1077 illustrated in FIG. 56) or asqueeze activation button or switch (such as switch 1097 illustrated inFIG. 57) to reduce the forces imparted on the wound. Though notrequired, the slide switches of the embodiments shown in FIGS. 55 and 56can be a reed switch with a sliding magnet. The slide switches can beconfigured to provide an illustration or indication of the position ofthe switch, for example, to alert a user that the switch is in aparticular position, such as in the on or active position. The switchmechanism can be used for battery isolation prior to operation of thepump or during sterilization, if sterilization is used. The switches inany of these embodiments can move the batteries into and out of contactwith the pump assembly such that, prior to operation, the battery can beout of contact with the battery terminals or other electricalconnections between the batteries and the pump assembly.

Any of the embodiments disclosed herein wherein the activation mechanismhas a sliding mechanism, a sliding switch, or other moving activationmechanism, including without limitation the embodiments illustrated inFIGS. 55-57, can have any of the features configured to prevent thepremature activation of the pump in the packaging supporting thedressing kit and pump assembly or otherwise. Additionally, any suchembodiments can be configured such that the packaging can be configuredto securely hold the pump assembly and/or battery module in adisconnected state.

For example, the dressing kit embodiments can be supported in thepackaging such that, while the dressing kit is supported in thepackaging, the components of the battery pack or pump assembly are heldin a first or non-operational position and prevented from moving to asecond operational position. In this configuration, when the componentsare in the first position, the pump is non-operational due to the factthat the battery terminals are not in contact with the one or morebatteries. For example, the packaging supporting the dressing kit canprevent a lid of the battery housing from moving to the second positionby holding the housing lid or cap in the first position. The packagingcan have protrusions that are positioned between the housing lid or capand the body of the battery housing that separate the battery housinglid from the body of the battery housing. Once the dressing kit isremoved from the packaging, the battery housing lid or cartridge can beslid inward, permitting the terminals to contact the batteries so thatthe pump can be activated. In this configuration, the battery housingcan serve as an activation button. Sliding the lid out of contact fromthe batteries can stop the operation of the pump. Further, the dressingkit can be configured such that sliding the batteries into engagementwith the battery terminals will result in an audible click, to alert auser regarding the position of the components of the battery enclosureor regarding whether the battery circuit is open or closed.

Any of the dressing kit embodiments disclosed herein can have a rotatingor wheel activation switch (such as the rotating switch 1117 illustratedin FIG. 58) or an axial sliding tab or reed (such as the sliding tabswitch 1137 illustrated as shown in FIG. 59) having two or morepositions corresponding to two or more pump operation positions. Forexample, the wheel switch 1117 can define an off position, as shown inFIG. 58B and an on position shown in FIG. 58C. A protrusion or bump 1117a on the wheel 1117 can be used to limit the rotational range of theswitch 1117, and one or more detents can be used to give tactilefeedback regarding the switch position and/or bias the switch to remainin the positions associated with the detents.

Similarly, the pull tab 1137 in FIG. 59 can trigger an operational stateif moved to a first position (such as by pulling the tab in thedirection indicated by arrow A1) and a non-operational state if moved toan opposite, second position (such as by pushing or pulling the tab inthe direction indicated by arrow A2). In some embodiments, though notrequired, the pull tab 1137 can have two end portions that can begrasped, such as first end portion 1137 a and second end portion 1137 b.Though not required, any of the switches or buttons of any of thedressing kit embodiments disclosed herein can have one or moreintermediary positions corresponding to different operation states, suchas different operational programs or otherwise. Detents or tabs on anyof the switches can be used to define the two or more operational statesor positions.

Additionally, as mentioned, for any of the switches or buttons of any ofthe dressing kits disclosed herein, the pump assemblies and/or batterymodules can be configured such that the position of the switch or buttondictates the position of the batteries relative to the battery terminalsor other electrical connections with the pump assembly. Further, as withany other embodiment disclosed herein, the packaging surrounding thedressing kit having the pull tab arrangement illustrated in FIG. 59 canbe configured such that the dressing kit with the pull tab fits in thepacking only when the pull tab is in the non-operational position.

In any of the pull tab arrangements disclosed herein, with reference toFIG. 60, the receiver or support 1159 for the pull tab 1157 can beconfigured such that the receiver or support 1159 must be squeezedinwardly to permit the pull tab 1157 to be slideable relative to thereceiver or support 1159. This can prevent or reduce the likelihood thatthe pull tab 1157 will be inadvertently moved to a different position.In use, a user can squeeze the receiver or support 1159 whilesimultaneously moving the switch 1157 to the desired position.

FIG. 61 illustrates an embodiment of a dressing kit 1170 having anarrangement of an isolator switch 1177 that can be used with any of thedressing kit embodiments disclosed herein, including the sliding switchembodiments. For example, the rotating or sliding switch 1177 can beformed from a non-conductive material and can be configured to open aswitch or spread a pair of contact terminals, such as first contactterminal 1179 a and 1179 b apart to prevent the flow of electricitybetween the two terminals 1179 a, 1179 b, when the switch 1177 is in afirst position (as illustrated in FIG. 61A). In some embodiments, theisolator can be a plastic tab or switch that rotates about a livinghinge. When moved to a second position (as illustrated in FIG. 61B), thecontact terminals 1179 a, 1179 b can in contact such that the electricalconnection can be closed and permit a flow of electricity through theelectrical connection. The batteries can be electrically isolated fromeach other and/or from the rest of the circuitry in this arrangement.

In any embodiments disclosed herein, as illustrated in FIG. 62, the pumpcan be activated by passing a key fob or activator 1217 over an RF IDreceiver 1219 positioned on the pump assembly 1214. This can eliminatethe force that would otherwise be imparted on the wound dressing duringactivation of the wound dressing. In some arrangements, as illustratedin FIG. 63, the activation button 1237 can be activated by infraredradiation, light, or by touch. This can reduce or eliminate the pressureexerted on the wound when switching the pump assembly between an on andan off state.

FIG. 64 illustrates a push button arrangement 1257 that can be used toactivate any of the pump assemblies disclosed herein. The push buttoncan have a flexible dome switch 1259 over a surface mount tact switch1261. A threshold level of reduced pressure can hold the flexible dome1259 in place as visual indicator that a sufficient level of reducedpressure is being exerted on the wound bed. In this arrangement, thebutton can serve as an activation switch and a tactile or visualindicator. The indicator can be used to alert the user to any or anycombination of the following conditions: user device is operatingcorrectly; leak detected; battery dead; and/or dressing saturated orfull.

As mentioned, any of the dressing kit embodiments disclosed herein canhave a visual pressure indicator configured to provide a visualindication of the pressure beneath the backing layer. The visualpressure indicator can be configured to change position in response to adifferential in pressure between the space beneath the backing layer andatmospheric pressure. In some embodiments, the pressure indicator orbubble can be configured to retract or collapse toward the wound surfacein response to increasing levels of reduced pressure beneath the backinglayer.

In some embodiments, the pressure indicator can have a different coloras compared to the remainder of the dressing, or can be configured tochange color in response to threshold pressure differentials between thespace beneath the backing layer and atmospheric pressure. The pressureindicator can be positioned in an opening or depression formed in thedressing to shield the pressure indicator from impact and to protect thepressure indicator. For example, as described above, the dressing kit330 of FIG. 19 can have one or more pressure indicators thereon.

The one or more pressure indicators can be supported in any desiredlocation on the dressing. With reference to FIG. 65, the pressureindicator 1270 can have a pressure bubble 1272 configured to be in anexpanded position (as shown in FIG. 65A) when the dressing is in afirst, low or no reduced pressure state and in a collapsed position (asshown in FIG. 65B) when the dressing is in a second, increased reducedpressure state. In any embodiments disclosed herein, the dressing canhave a pressure bubble (such as pressure bubble 1272) positioned over amembrane (such as membrane 1274), which can be stretchable orsubstantially stretchable. The membrane 1274 can be formed from amaterial that is gas permeable, but liquid impermeable in someembodiments. The membrane 1274 can be configured to be substantially orcompletely opaque in a first, relaxed state and less opaque (i.e., moretranslucent) in a second, more depressed state. Alternatively, themembrane material can be somewhat translucent in the first, unstretchedstate and more translucent in a second, stretched state. Reducedpressure imparted on the dressing can cause the membrane to depress ormove from the first toward the second state.

In some embodiments, the membrane can be substantially opaque exceptwhen in contact with the colored material or liquid 1276 beneath themembrane 1274. When the membrane 1274 contacts the liquid or solidmaterial 1276 beneath the membrane 1274, the color of such liquid orsolid material 1276 can become more visible such that the color becomesapparent when a threshold level of reduced pressure is exerted on themembrane 1274, causing it to more toward the colored material.

As mentioned, a colored material such as ink or other material can bepositioned under the membrane. The dressing can be configured such thatthe membrane layer between the pressure bubble and the colored materialis substantially more visible in the second state than in the firststate, permitting the user to visually inspect the level of reducedpressure in the overlay by visually monitoring the color under thepressure bubble. In some arrangements, the pressure bubble can bevisually observed after depressing the button.

Other pressure indicators can be supported by the wound dressing. Forexample, as illustrated in FIG. 66, a wound dressing can have aplurality of pressure indicators 1270 (of any suitable configuration orconfiguration disclosed with respect to any embodiments disclosedherein) positioned about a top surface of the dressing to provide avisual and/or a tactile indication of a level of negative pressurebeneath the dressing overlay 1272. The plurality of indicators 1270 canhave a plurality of pressure bubbles activated by reduced pressure. Insome embodiments, the pressure bubbles or indicators can have a coloredsubstance or material beneath the dome of the indicator, or a lightbeneath the indicator to enhance the visual appearance of the indicator.In some embodiments, the pressure indicators 1270 can be configured todefine two states or positions—a depressed or collapsed position when athreshold level of reduced pressure is present under the overlay and anextended or inflated position when no pressure or less than thethreshold pressure is present under the overlay. In some embodiments,the pressure indicators 1270 can also define intermediate positions.

The pressure indicators or bubbles can be mounted on a panel or formedin a panel arrangement and can have any suitable shape or size. Thepressure indicators can be integrally formed with the overlay material,or can be integrally formed in a panel arrangement that can be attachedto or mounted on the overlay. Additionally, the pressure indicators canbe individually formed. In any embodiments disclosed herein, a pressureindicator can be positioned in each of four corners on the overlay.

With reference to FIGS. 67-70, any dressing kit embodiments disclosedherein can have an indicator light 1290 supported by or embedded withinthe dressing to provide a visual indication of one or more of theoperating parameters of the dressing, pump assembly, or battery modules.In some embodiments, the light 1290 can be positioned such that it isvisible from two or more planes or directions. Additionally, the lightcan be supported on a protrusion projecting from an outside surface ofthe dressing so that the light 1290 is more visible from a greaternumber of angles. The light 1290 can be an incandescent light, and LEDlight, or any other suitable light and can be constant or pulsating, orprogrammable. Additionally, the light 1290 can be configured to changeintensity of the light output and can be programmed to graduallyincrease and decrease the light output.

With reference to FIGS. 68, 69, and 70, in some embodiments, thedressing can have a soft or diffused light (as in FIG. 68), a light ring(as in FIG. 69), or an array of lights (as in FIG. 70). As shown in FIG.68, the dressing can have a discrete diffused light area. The light areacan be a continuously lit area, providing reassurance that the dressingand pump assembly is operating correctly.

As shown in FIG. 70, the dressing can support a panel of lights 1290that is configured to provide an indication of a magnitude of a readingor level within the overlay, or a level of power in the power source.For example, in any embodiments disclosed herein, for light basedpressure sensors, temperature sensors, or saturation sensors orindicators, the number of lights illuminated in an array of lights canincrease as a level of reduced pressure, level of temperature, orsaturation level under the overlay increases. The lights can also beused to indicate a duration of therapy, or a remaining duration oftherapy. Multiple light arrays can be used to indicate multipleindications. Additionally, any of the lights disclosed herein can beconfigured to pulse or flash to provide a variety of signals regarding avariety of conditions to a user. Any of the lights disclosed herein canbe LED lights.

Further, as shown in FIG. 69, any of the user buttons on the dressingcan have lights integrated into the button design. In any embodimentsdisclosed herein, the light can surround the button so that a user caneasily locate the button.

In any embodiments disclosed herein, as is shown for the embodiment ofthe dressing kit 1310 shown in FIG. 71, the dressing can have shapedfeatures 1312 positioned on a surface of the dressing 1314 that arefully revealed and identifiable by touch only when a threshold level ofreduced pressure is achieved in the dressing. FIG. 71A shows thedressing 1310 in first state, where less than a threshold level ofreduced pressure exists under the overlay 1316. The dressing can be in afirst state when the pump is not operational or when less than theoptimal level of reduced pressure is present under the overlay 1316.Dressing components or the strength of the overlay layer 1316 can holdthe overlay layer 1316 in a raised position so that the overlay layer1316 (i.e., the outermost layer) does not collapse under gravity againstthe foam or other materials below the overlay layer 1316. The dressing1310 can be configured such that, when a sufficient or threshold levelof reduced pressure exists under the overlay 1316, the overlay layer1316 collapses against a top surface or a top layer 1314 of the packingmaterial or materials, as shown in FIG. 71B. When this occurs, in someembodiments, a color of the packing material layer 1314 can be revealedthrough the overlay 1316.

Additionally, with reference to FIG. 72, in any embodiments disclosedherein, the dressing can have a one or more discrete openings ordepressions 1332 for detecting a level or a threshold level of reducedpressure under the backing layer 1333. In any embodiments disclosedherein, the top surface or top layer 1334 of the packing material candefine one or more raised, depressed, and/or colored features 1336 thathave a shape that departs from the surface of the packing material. Forexample, though not required, the packing material 1334 can have one ormore protrusions or tactile bubbles 1336 projecting away from thesurface of the packing material 1334. Further, in some embodiments, thefeatures can be depressions or even holes or openings formed through orinto the top surface 1334 of the packing material. The features can besized, positioned, and configured such that a user can see and/or feelthe features more when the dressing backing layer is in the second statethan in the first state.

In any embodiments disclosed herein, at least the top layer or topsurface of the packing material can be a different color than the othermaterials comprising the dressing. The dressing can be configured suchthat the color of the packing material is substantially only visible, oris visibly darker or different, when the dressing is in the secondreduced pressure state than when it is in the first state.

With reference to FIG. 72, the dressing 1333 can be configured such thatthe deflecting membrane 1332 changes color in the presence of moistureand/or pressure. In some embodiments, the dressing can be configuredsuch that the dressing reveals a different color substrate under thebacking layer 1333 when the backing layer 1333 is collapsed against thepacking material. Any of the dressing kit or dressing embodimentsdisclosed herein can have any or any combination of the featuresdisclosed in the embodiment of the dressing illustrated in FIG. 71 or72, or otherwise.

Any of the dressing kit embodiments disclosed herein can have avibration buzzer 1352 that can be tethered to the dressing 1354 (asshown in FIG. 73), or can have an audible alarm or alert function 1362(as shown in FIG. 74). The vibration alarm or buzzer 1352 or audiblealarm or buzzer 1362 can be configured to alarm or alert a user to aparticular condition regarding the wound dressing, pump, batteries, orany other component of the dressing kit. This can provide the user withfeedback regarding the performance of the pump without requiring theuser to see the pump, which can be particularly beneficial when the pumpis worn under clothing or in any other fashion or manner that concealsthe dressing or pump. The vibration buzzer can be mounted directly to apatient's skin, to the dressing, or otherwise. The vibration buzzer canhave combination of any of the other features disclosed herein. In someembodiments, the vibration buzzer use the pump assembly to provide thevibration. On/off patterns of the pump can be used to provide thedesired vibration or alert. Additionally, the audible alarm or buzzercan be positioned or supported apart from the dressing.

In any embodiments disclosed herein, the dressing can have one or moresensors therein that can trigger an alarm when a threshold level or whenone or more predetermined levels of saturation within the dressing hasbeen reached. For example, the dressing can be configured to trigger afirst alarm when a first level of saturation has been reached, totrigger a second alarm when a second level of saturation has beenreached, to trigger a third alarm when a third level of saturation hasbeen reached, and so on, wherein the level of saturation is the level offullness of the dressing. In some embodiments, the sensors can bepositioned within the absorption layers of the dressing and can beconfigured to generate a signal based on exposure to liquid within thedressing. For example, one or more hygroscopic sensors could bepositioned under the backing layer of the overlay. The sensors can bepositioned within the dressing layers, and discrete locations about thedressing layers to monitor the amount of liquid throughout the dressinglayers. For example, in any embodiments disclosed herein, between 2 and4 sensors can be positioned symmetrically about the dressing layers, orbetween 4 and 6 sensors can be positioned symmetrically about thedressing layers. Some embodiments of the dressing kit can have onesensor positioned under the backing layer. In any embodiments disclosedherein, one or more sensors can be positioned adjacent to the port tothe pump assembly. Without limitation, the first level can be atapproximately 60% saturation, the second level can be at approximately75% saturation, and the third level can be at approximately 90%saturation. In some embodiments, the first level can be fromapproximately 60% saturation to approximately 70% saturation, the secondlevel can be from approximately 70% saturation to approximately 80%saturation, and the third level can be from approximately 80% saturationto approximately 90% saturation. In some embodiments, the saturationlevel can be detected using one or more resistance or capacitancesensors (such as a humidity or moisture sensor based on resistivity orcapacitance) positioned within the dressing. In any embodimentsdisclosed herein, the moisture sensor can be positioned close to oradjacent the wound facing side of the filter or otherwise adjacent tothe pump assembly or port to indicate the dressing is saturated or thefluid level is close to the level that will result in blockage to thefilter, which could inhibit further negative pressure transmission fromthe pump assembly.

In any of the embodiments disclosed herein, with reference to FIG. 75,the dressing 1370 can have one or more saturation indicators 1372. Forexample, without limitation, any of the dressings can have one or moremarkings or indicators 1372 on the backing layer to indicate or reveal alevel of exudate in the dressing when the exudate reaches a thresholdlevel. The indicator can be a clear or transparent window in anotherwise opaque dressing. The dressing can have instructional textaround or adjacent to the window to provide a user with instructionsregarding how to use the saturation indicator. Additionally, suchsaturation indicators could be positioned at a variety of differentlocations on the dressing. Any of the dressing embodiments disclosedherein can have this feature.

Similarly, with reference to FIG. 76, any dressing embodiments disclosedherein can have one or more fill line indicators 1382 to help a user ormedical practitioner assess a level of exudate within a dressing. Thefill line indicators 1382 could be lines of substantially transparentappearance across a surface of the dressing, or could be printed linesor markings on the overlay. The fill line indicator can be used toassess when a dressing is ready for changing. With reference to FIG. 77,any embodiments disclosed herein can have a plurality of viewing windows1392 supported by the backing layer or can have one or more openings ordepressions formed in the packing material to permit a user to detect alevel of exudate or saturation of the dressing.

As illustrated in FIG. 78, any dressing kit embodiments disclosed hereincan be configured to produce a motor pulse or sound to indicate in acontrolled manner that the device is working correctly. For example, thedressing kit 1400 can have a pump motor 1402 that can be configured toproduce a sound and/or vibration that repeats at regular intervals orfollowing regular patterns.

With reference to FIG. 79A, any embodiments disclosed herein can beconfigured to have a bubble indicator 1410 that serves as a pressureindicator, but which also activates the device, similar to one or moreof the other embodiments described above. The bubble indicator will bein communication with the space between the cover layer 1412 and thewound, and can be configured to depress a switch 1413 when depressed.This establishes a clear communication between a working device and theinteraction to restart it. As with other embodiments disclosed herein,with a color change material positioned under the bubble, as shown inFIG. 79B, the collapse of the pressure bubble under reduced pressure canreveal a colored bottom to the indicator 1412.

With reference to FIG. 80, any of the pressure indicators disclosedherein can have two or more different colors to help a user bettervisualize the position of the indicator and, hence, the condition underthe overlay. For example, a first colored ring 1432 could be positionedaround the protrusion 1433, and the protrusion 1433 can have a similarlycolored top surface such that, when the protrusion is collapsed, thecolor of the top 1434 of the protrusion 1433 matches the colorsurrounding the protrusion so that it is clear that the protrusion iscollapsed. When less than a sufficient amount of reduced pressure isexerted on the overlay such that the protrusion 1433 extends away fromthe cover of the overlay, a different colored portion of the protrusioncan contrast with the color surrounding the overlay to provide a clearindication to a user that the protrusion 1433 is extended and that aless than optimal amount of reduced pressure is present under theoverlay. In some embodiments, the color separation or differentiation onthe protrusion or indicator can add an extra visual indication that thedevice requires re-activation. A red side wall can indicate that thedevice has lost the vacuum or that less than the threshold vacuum levelis present.

With reference to the embodiment depicted in FIG. 81, any of thedressing kit embodiments disclosed herein can have a plurality ofdiscrete depressions, openings, or other features 1452 formed in a topsurface of the packing layers 1454 that can be used to provide a visualand/or tactile indication of the level of reduced pressure beneath abacking layer. In some embodiments, openings 1456 can pass through to alower layer 1458 of the dressing 1450. In this configuration, when thedressing 1450 is in an operational state, the backing layer to be drawninto or toward the depressions, but relaxed when the dressing is not inan operational state.

FIG. 82 illustrates another embodiment of a dressing kit 1470 having adressing member 1472, a pump assembly 1474, and a power source 1476(which can be housed within a housing 1477 that also houses the pumpassembly, or can be distributed across the dressing member 1472, orotherwise). A conduit 1478 can be used to transfer the negative pressurefrom within the pump assembly 1474 to the dressing member 1472. Thedressing member 1472 can have a pocket member 1480 positioned adjacentto the dressing layers 1473 or positioned above the dressing layers 1473and can be used to removably support the housing 1477 for the pumpassembly 1474 and/or the power source 1476. With reference to FIG. 82B,the housing 1477 can be removed from the pocket member 1480 forservicing, battery replacement, or to position the housing 1477 in adifferent location apart from the dressing for comfort, etc.

FIG. 83 illustrates a carrier 1490 for a pump assembly 1494 that can beused with any of the pump assemblies or dressing kits disclosed herein.The carrier 1490 can be worn on a person's belt or otherwise clippedonto a person's clothing.

In some embodiments, such as the embodiment of the noise attenuatingsystem 1510 illustrated in FIGS. 84A-B, a special pouch or overmold 1512can be formed to surround any of the pump assemblies disclosed herein.The overmold 1512 can be formed from silicone, rubber, foam, and/or anyother material available configured to attenuate the noise and/orvibration of the pump assembly. Additionally, a special pouch orovermold 1514 can be formed to surround any of the pump motorembodiments disclosed herein. The overmold 1514 can be formed fromsilicone, rubber, foam, and/or any other material available configuredto attenuate the noise and/or vibration of the pump motor. In someembodiments, an overmold 1516 for a pump motor can have a slot 1518therein along a length of the wall portion of the overmold 1516. In oneembodiment, the noise attenuating system comprises foam and a siliconeboot. In another embodiment, it comprises silicone overmolding on motorand pump.

With reference to FIGS. 85A-E, any of the dressing kit embodimentsdisclosed herein can have one or more support handle member 1551removably positioned around a periphery of the dressing 1552 to providesupport to the dressing 1552 during application of the dressing 1552 tothe body. The support handle member 1551 can increase the stiffness and,hence, reduce the floppiness, of the dressing 1552 to facilitatehandleability of the dressing 1552. Providing the additional support onthe dressing can be very important to the application of the dressing1552 to the body, in light of the weight of the pump assembly andbatteries on the dressing 1552. The support can be formed from paper,and plastic film, or any other suitable material. Additionally,instructions or other information can be printed on the supportmaterial.

In some embodiments, the support handle member 1551 can have a firstlengthwise portion 1551 a and a second lengthwise portion 1551 apositioned between the dressing layers 1553 and an outer perimeter 1552a of the dressing member 1552. In some embodiments, the first and secondlengthwise portions 1551 a can be interconnected. Additionally, thesupport handle member 1551 can have a first end portion 1551 b and asecond end portion 1551 b positioned between the dressing layers 1553and an outer perimeter 1552 a of the dressing member 1552. In someembodiments, the first and second end portions 1551 b can beinterconnected. Additionally, in some embodiments, the support handlemember 1551 can have a housing or third portion 1557 configured to coveran end portion of the dressing member 1552. For example, one or morebuttons, switches, a pump assembly, a power source, and/or otherfeatures can be protectably supported under the third portion 1557 ofthe support handle member 1551. The support handle member 1551 can beconfigured to activate the pump upon removal. In some embodiments, thesupport handle member can be continuous such that each portion isinterconnected.

Features, materials, characteristics, or groups described in conjunctionwith a particular aspect, embodiment, or example are to be understood tobe applicable to any other aspect, embodiment or example describedherein unless incompatible therewith. All of the features disclosed inthis specification (including any accompanying claims, abstract anddrawings), and/or all of the steps of any method or process sodisclosed, may be combined in any combination, except combinations whereat least some of such features and/or steps are mutually exclusive. Theprotection is not restricted to the details of any foregoingembodiments. The protection extends to any novel one, or any novelcombination, of the features disclosed in this specification (includingany accompanying claims, abstract and drawings), or to any novel one, orany novel combination, of the steps of any method or process sodisclosed.

While certain embodiments have been described, these embodiments havebeen presented by way of example only, and are not intended to limit thescope of protection. Indeed, the novel methods and systems describedherein may be embodied in a variety of other forms. Furthermore, variousomissions, substitutions and changes in the form of the methods andsystems described herein may be made. Those skilled in the art willappreciate that in some embodiments, the actual steps taken in theprocesses illustrated and/or disclosed may differ from those shown inthe figures. Depending on the embodiment, certain of the steps describedabove may be removed, others may be added. Accordingly, the scope of thepresent disclosure is intended to be defined only by reference to theappended claims. The accompanying claims and their equivalents areintended to cover such forms or modifications as would fall within thescope and spirit of the protection. Furthermore, the features andattributes of the specific embodiments disclosed above may be combinedin different ways to form additional embodiments, all of which fallwithin the scope of the present disclosure. Although the presentdisclosure provides certain preferred embodiments and applications,other embodiments that are apparent to those of ordinary skill in theart, including embodiments which do not provide all of the features andadvantages set forth herein, are also within the scope of thisdisclosure. Accordingly, the scope of the present disclosure is intendedto be defined only by reference to the appended claims.

What is claimed is:
 1. A wound dressing kit for reduced pressure wound therapy, comprising: a pump assembly; a power source; and a dressing member having one or more absorptive layers and a fluid impermeable backing layer, and defining a first dressing portion and a second dressing portion; a score along at least a portion of the dressing member between the first and the second dressing portions, the score being configured to increase the tearability of the dressing member between the first and second dressing portions; wherein: the first dressing portion is configured to support the one or more absorptive layers; and the second dressing portion is configured to support at least one of the pump assembly and the power source; and wherein the backing layer is configured to form a sealed enclosure over the one or more absorptive layers, the pump assembly, and the power source; wherein the power source is removable from the pump assembly by tearing the dressing member along a score in the second dressing portion between the power source and the pump assembly; and wherein the dressing member is configured such that the sealed enclosure is maintained in at least one of the first dressing portion or the second dressing portion after the dressing member is torn along the score between the power source and the pump assembly.
 2. The wound dressing kit of claim 1, wherein the pump assembly comprises a voice coil actuated pump.
 3. The wound dressing kit of claim 1, wherein the power source comprises one or more batteries.
 4. The wound dressing kit of claim 1, wherein the power source comprises one or more printed batteries.
 5. The wound dressing kit of claim 1, wherein the power source comprises one or more flexible batteries.
 6. The wound dressing kit of claim 1, wherein the pump assembly is powered by one or more air activatable batteries.
 7. The wound dressing kit of claim 1, wherein the pump assembly is at least partially powered by one or more photovoltaic cells.
 8. The wound dressing kit of claim 1, wherein the pump assembly is at least partially powered by one or more photovoltaic cells positioned about at least one of the backing layer, a housing for the pump assembly, and a conduit configured to communicate a negative pressure provided by the pump assembly to the one or more absorptive layers.
 9. The wound dressing kit of claim 1, wherein the pump assembly is at least partially powered by one or more batteries attachable to the dressing member using snap connectors, adhesive, Velcro, a housing having a closeable opening, or a pouch supported by the dressing member.
 10. The wound dressing kit of claim 1, further comprising a flexible hinge positioned between the power source and the pump assembly to improve the flexibility and conformability of the portion of the dressing kit supporting the pump assembly and the power source. 